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UCB jobs in Raleigh, NC - 38 jobs

  • Head of Statistical Innovation (US - Raleigh)

    UCB 4.3company rating

    UCB job in Raleigh, NC

    Make your mark for patients We are looking for a Head of Statistical Innovation to join us in our Biometrics & Data Science team, based in any of our Brussels (Belgium), Monheim (Germany), Slough (UK) or Atlanta or Raleigh (US) offices. About the role This is a critical enterprise-level leadership role that will shape the future of drug development by driving innovation in statistical design, analysis, and interpretation across all phases of research and development, from early discovery to post-market surveillance. The Head of Statistical Innovation will be responsible for fostering a culture of statistical excellence, influencing strategic decision-making, and ensuring the robust application of cutting-edge quantitative methods to address complex scientific questions. Who you'll work with You will report into the Head of Advanced Methods & Data Science What you'll do Establish and maintain a positive image for UCB statistics worldwide through collaborations, scholarship and professional networking Create a vision and mission for Statistical Innovation and Consultancy within UCB and champion its visibility both internally and externally with the academic, regulatory and scientific community to influence policies and state-of-the-art statistical thinking related to drug development. Provide statistical advice and guidance to the UCB statistical leadership and Senior Management to enable optimal decisions in development, marketing, and lifecycle support of UCB products. Provides strategic counsel to senior executives on quantitative innovation, analytics and opportunity/impact in program strategy/design, mitigations and innovation-enabled excellence with modern analytics and digital business transformation Lead development and championing techniques based on state-of-the-art statistical research and seek creative solutions through collaborations and interactions with other experts for drug development problems. Provide, together with UCB statistical leaders, statistical thought leadership for establishing high-quality, regulatory-compliant statistical approaches to provide well-trained statistical staff at all sites. Interested? For this position you'll need the following education, experience and skills: PhD. required Several years pharmaceutical industry experience with proven successful track record in biopharmaceutical development. Experience successfully building and managing international teams in the field of statistical sciences Proven track record of successful internal and external stakeholder engagement Inspirational leader, able to develop and communicate a vision for the Practice across cultures and geographies Change agent, driving change and innovation to maximize patient value creation Strong publication track record Are you ready to ‘go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you! About us UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science. Why work with us? At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential. UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable federal, state, or local law. UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment, your employment with UCB, or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws, orders, and regulations. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US-Reasonable_Accommodation@ucb.com for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
    $74k-116k yearly est. 60d+ ago
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  • Benefit Risk Scientist

    UCB 4.3company rating

    UCB job in Raleigh, NC

    Make your mark for patients We are looking for a Benefit Risk Scientist who is analytical, collaborative, and detail-oriented to join us in our Patient Benefit Risk and Medical Safety team, based in our Raleigh, North Carolina office. About the role You will contribute to the evaluation, interpretation, and communication of benefit-risk insights across several medicines at different stages of development. You will support the creation of safety and benefit-risk strategies, contribute to scientific documentation, and ensure high‑quality analyses aligned with regulatory requirements. Who you'll work with You will be working in a team that collaborates closely with medical, clinical, statistical, and regulatory colleagues. You will partner with Benefit Risk Leads and cross-functional teams to monitor and communicate the benefit-risk profile of each medicine. What you'll do * Analyze and interpret data from multiple sources to identify and assess potential new risks and incorporate findings into benefit-risk plans. * Support the implementation of safety monitoring and risk management strategies in clinical development programs. * Prepare and contribute to high‑quality benefit-risk and safety documentation for regulatory submissions. * Ensure scientific accuracy, clarity, and compliance in all written deliverables. * Collaborate with stakeholders to ensure timely escalation and alignment on safety topics. * Stay current on scientific and regulatory developments relevant to benefit-risk assessment. Interested? For this position, you'll need the following education, experience and skills: Minimum Qualifications: * Bachelor's degree * Minimum 2 years' experience in the biopharmaceutical industry with exposure to safety evaluation or benefit-risk assessment. Preferred Qualifications: * Advanced degree in a scientific field (MD, PharmD, PhD). * Strong scientific writing skills with the ability to learn different systems quickly. * Demonstrable experience in supporting multiple safety-related outputs and working knowledge of the international regulations governing drug safety. * Ability to analyze complex data and communicate findings clearly. * Strong organizational skills with the ability to work on multiple projects. * Excellent written and verbal communication skills in English. * Ability to adapt in dynamic environments and apply sound judgement. This position's reasonably anticipated base salary range is $124,000-$163,000 annually. The actual salary offered will take into account internal equity and may also vary depending on the candidate's geographic region, job-related knowledge, skills and experience, among other factors. Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you! About us UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science. Why work with us? At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential. At UCB, we've embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office. UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
    $52k-73k yearly est. 31d ago
  • Warehouse Operator

    Endo 4.7company rating

    Raleigh, NC job

    Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary The Warehouse Operator will be assigned to the shipping floor /general warehousing areas. S/he is responsible for daily duties of shipping finished goods and handling inventory by executing instructions issued by the Shipping and Receiving Supervisor, and continuously improving cGMP environment. Executes customers' orders to meet and exceed their expectations in a safe, efficient and timely manner while upholding the high standards of the company and complying with all company policies. The Warehouse operator may, from time to time, be called upon to support the Receiving group. Job Description ESSENTIAL FUNCTIONS: The Operator will be assigned the positions of Picker, Packer, Loader, or Rover on a rotating weekly basis. S/he will be accountable for the performance of each position's duties as assigned for the week. Picker Lead morning exercises. Picks, set down and stage products in accordance with the daily plan, available staging area and the picking ticket. Visually inspects pallets during set down and mark any damaged pallets or products observed. Ensures a minimum of two orders are fully set down at all times during the business day, one being loaded, and one being packed. Seeks support from the Rover to achieve this duty when needed. Marks/identifies each order with cone markers. Group lots together as picked. Places a marker at any change in lots and identify mixed lot pallets. Keeps all documents attached to clip boards and keeps clip boards in designated area with the order. Ensures a minimum of 1 ½ loads are set down at the end of the day. Completes all required shipping documents including standard operating procedures (SOPs). Supports teammates as needed. Packer Inspects all drums, bags, pallets, slip sheets and identify. Corrects or rejects any defect in accordance with SOPs. Labels and/or marks all products and pallets as required. Cleans, adjusts, changes pallets and applies any special packing requirements in final preparation before wrapping. Ensures only drums assigned to the order are packed and any restricted or rejected drums not included. Scans or checks off all items in completion of packing an order and issues a “No Errors” report. Ensures one order is completely packed and ready for loading before the last pallet of the preceding order is loaded. Ensures one order is completely packed and ready for loading the next day. Seeks support from the Rover when an order may not be prepared in time for the Loader team. Completes all required shipping documents including SOPs. Keeps all documents attached to clipboards and keep clipboard in designated area with the order. Keeps bags and drums free from foreign materials. Reports damaged containers within one hour of discovery. Supports teammates as needed. Rover Empties trash cans and dumpster daily. Submits inventory supply list weekly. Completes 5S board daily. Assists Packer to meet the requirement of a minimum of 1 load on the floor fully packed and ready to be loaded. Assists or replace Picker or Loader or as needed due to assignment demands or absenteeism. Picks, packs, and stages rejects. This must be completed no later than the close of the next business day after issuance. Picks, packs, ships, other orders or miscellaneous shipments other than Finish Goods. Delivers shipping documents/labels to other departments and pick up supplies or items from other departments. Empties scrap wood bin at least once per week or as needed. Picks up or return pallets and scrap pallets. Completes and submits pallet transfer documents. Consolidates rows and racks when no rejects are needed. Loader Wraps or bands pallets as specified in SOPs and special instructions. Applies pallet labels, slip sheets or covers as required. Loads trailers using best configurations and customer specifications. Blocks and braces loads while loading trailers. Inspects, maintains, and operates wrappers. Alternates “Trailer Loader” and Wrapper Loader” with each load. Completes all required shipping document including SOPs. Supports teammates as needed. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Other duties as assigned with or without accommodation. These are duties in additional to the assigned duties of the Picker, Packer, Rover, and Loader positions. Identifies and evaluates the cause of areas of concern, problem areas or opportunities and offers practical solutions for continuous improvement in customer satisfaction, efficiency and safety. Have a working knowledge of all tools and equipment utilized in the warehouse. Utilizes software system(s) to identify order specifications, products, and inventory specifications. Complies with department and company policies including but not limited to; “Cardinal Rules”, PTO, start times, breaks, safety and cGMP practices. Completes and passes all training modules and courses by their specified completion date. Maintains designated zone in a continuously clean, orderly condition. Completes daily assigned work as per the Daily Pack and Load Plan. Alerts the Logistics Supervisor by speaking directly with him/her immediately if you believe you are unable to meet any of the duties as described. In the Supervisor absence, speaks directly with the Logistics Manager. MINIMUM REQUIREMENTS: Education: High School Diploma, GED, or equivalent. Experience: Minimum 3 years experience in a cGMP warehouse with particular knowledge of safety procedures, equipment operations, troubleshooting, and using proper work procedures. Possess a valid Driver's License. Computer literate with skills in Microsoft Office. Preferred Skills/Qualifications: Other Skills: Competencies: Must have excellent communication skills. Working knowledge of the metric system and the ability to convert kilograms to pounds. Some Lean Manufacturing knowledge and experience is a plus. Ability to operate Warehouse shipping equipment, e.g., fork truck, trailer spotting tractor (Yard Dawg), use power equipment, hand tools, bar code scanners and basic computer. Written Communication, Problem Solving, Interpersonal Savvy, Organizing RELATIONSHIP WITH OTHERS/ SCOPE: Directly reports to Shipping and Receiving Supervisor. Although responsibilities are governed by policies and procedures, much of the work is performed without direct supervision; therefore, personal judgment must be exercised in pacing the work and adhering to the highest standard of quality in the absence of supervision. Frequently maneuvers large, heavy drums filled with product (100 to 220 lbs.) manually while loading trucks or preparing orders. This handling includes rolling and pushing/pulling requiring 80 lbs. /force. Further exertion is required to strap drums on a pallet as well as rolling and stacking drums while loading trucks. Must be able to withstand extreme heat and cold when working loading trucks. Must be able to visually identify an ever-increasing number of products and codes at a glance. A great deal of awareness is required to understand shipping instructions and to interpret the many guidelines for each functional procedure. Must be able to enter and transact inventory data and order information in the computerized system(s). Must be able to safely and efficiently operate forklifts, shrink wrappers, spotting tractors, power tools, strapping tools, safety equipment, bar code scan guns, ladders, a number of hand tools and miscellaneous equipment. Must handle and package finished goods with care to avoid product damage, which could result in customer rejection of product. Not directly responsible for work of others; although the team concept requires coordinated efforts such as driving forklifts, loading, labeling, checking and double-checking of inventory items or picked/packed finished goods. Must be able to communicate and work with all departments and personnel on site. WORKING CONDITIONS: All work is performed in unheated and uncooled environments; this includes working site outside and in trailers in all types of weather. The constant use of dangerous equipment and handling of hazardous materials presents an ever-present hazardous working environment. Occasional heavy lifting (up to 68 pounds without assistance), bending, climbing, use of hand and power tools. Frequent pushing/pulling of maneuvering heavy drums using 80 lbs. of force, walking, climbing, reaching, handling/grasping. Must be able to wear the required personal protective equipment (PPE), as deemed necessary for each job task as assigned by EH&S. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
    $30k-37k yearly est. Auto-Apply 60d+ ago
  • Pharmaceutical Operator 1

    Endo Pharmaceuticals Inc. 4.7company rating

    Raleigh, NC job

    Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary SUMMARY OF POSITION: This position is responsible for operating large scale manufacturing equipment to produce bulk organic chemicals in accordance with Company standards and operating procedures. He/she will be responsible for reports and documentation. Must be able to pay attention to detail due to the nature of chemicals and environment he/she will be working in on a daily basis. Job Description ESSENTIAL FUNCTIONS: Operates in a regulated environment and complies with all cGMP and OSHA regulations applicable to manufacturing responsibilities. This includes wearing appropriate personnel protection equipment (PPE), understanding and following all applicable standard operating procedures, work instructions, and standard work practices applicable to job responsibilities Operates and monitors dryers, mills, sifters, and other miscellaneous equipment through manual operations, panel boards, indicators, PLC displays, and DCS screens following applicable batch records, procedures and good documentation practices Packages, weighs, samples, and labels finished and intermediate products following applicable procedures and good manufacturing practices Maintains detailed operating reports and logs, including notes on problems and records on added weights, volumes, measured temperatures, pH levels, pressures, and flow rates following applicable procedures and as directed by supervisor Delivers samples to laboratory and retrieves operating supplies from storeroom Cleans and maintains work area, process equipment, tools and safety supplies according to regulatory and Company standards and operating procedures. Other duties as assigned by Management DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Monitors environmental and safety devices (scrubbers, ruptured discs, etc.) to insure that the equipment is functioning properly. Performs Lock Out/Tag Out (LOTO) independently. Operates fork lifts, hoists, and other material handling devices to physically move bulk raw materials, WIP, and packaged goods to and from pick-up points Participate in various employee involvement teams and committees, such as Area/Site Safety Teams, kaizen events, Hazmat and/or Cost Savings Teams, to improve the workplace, increase efficiency, and improve productivity MINIMUM REQUIREMENTS: Education: High School Diploma, GED, or equivalent required. Associate or Technical degree preferred. Experience: Previous GMP/ISO manufacturing experience preferred Skills/Qualifications: Skills/Competencies: Other Skills: Must be able to read and follow detailed instructions and procedures, and effectively communicate in both verbal and written formats. Must be able to perform basic math. Must have a working knowledge of chemical processing equipment and associated safety requirements. Possess sound decision making skills. Action Oriented, Informing, Computer Skills (MS Office and E-mail), Problem Solving, and Teams Must work in a team environment to cover work stations during breaks and lunches Must be able to wear the required Personal Protective Equipment (PPE) required for the job or task. Sound decision making skills. Action Oriented, Informing, Computer Skills (MS Office and E-mail), Problem Solving, and Teams RELATIONSHIP WITH OTHERS/ SCOPE: Performs diversified duties following standard procedures and under the direction of a production supervisor or lead operator. Requires a high level of safety awareness and ability to determine when equipment is not performing to standards or expectations. Responsible for proper operation of processing equipment to ensure optimum production of high quality products. Mistakes and errors normally result in unacceptable product and or mechanical equipment damage. As a result, impacts our product status in the market place. Understands the misuse of processing equipment could result in serious injuries to self and others due to the potentially dangerous nature of the equipment and the chemicals being processed. No direct responsibility for the work of others; however, the team approach is emphasized in order to cover work stations during breaks and lunches. Furthermore, the “buddy system” for training new operators creates additional responsibility. WORKING CONDITIONS: The plants open-air construction exposes operators to the normal year-round outside climate. Some relief from the elements is available in the control rooms and break area. Dirty conditions and chemical fumes are occasionally present in the work areas. Must handle average to heavy weight materials by hand. Material handling devices (e.g., hand truck, for truck, and conveyors) are used when possible but use of proper lifting and movement techniques is necessary to prevent injury. Must be able to physically climb stairs and evacuation ladders, rolling drums, lifting and pouring bags of raw materials, driving forklifts, climbing and entering reaction vessels and perform first aid. Injuries could result from spills or leaks of corrosive flammable, and toxic material, all of which are normally handled in the plant Must be able to work rotating 12 hours/day shift and occasional overtime as needed. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
    $36k-44k yearly est. Auto-Apply 60d+ ago
  • Strategic Account Manager- Vaccines, Raleigh, NC

    Sanofi Us 4.3company rating

    Raleigh, NC job

    Job Title: Strategic Account Manager- Vaccines About the Job Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you'll help advance prevention on a global scale - and shape the future of immunization. The Strategic Account Management organization is a highly skilled forward-thinking sales team serving our largest and most complex customers, while also managing our highest valued vaccine contracts. The customers we call on primarily include Health Systems, IHNs, Medical Groups, PBGs, FQHCs and state Awardees. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities: Assume the leadership role within assigned accounts, providing overall account leadership to cross-functional internal and external team members as needed. In this capacity, the SAM will assume responsibility for assigned strategic customers and manage each as a business partnership on behalf of Sanofi. Additionally, the SAM will bear full responsibility for building a strategic account plan for assigned accounts, as well as organizing and deploying the appropriate resources within Sanofi to drive value co-creation with customers and meet/exceed Sanofi's revenue targets. Effectively manage and grow a network of trust-based relationships with external stakeholders to generate revenue through genuine partnerships within Sanofi's largest and most complex customers. The SAM will develop a deep understanding of the customer's business which includes their pressures and drivers, priorities, as well as their related challenges and opportunities. They will maintain working knowledge of the customer's business model, strategic goals and objectives, and their position within the healthcare environment including value-based health care, their competitors, and financial levers. Identify and qualify high value opportunities within their accounts by working directly with the customer to develop and drive growth strategies, team-to-team alignment, and executive relationships together with internal cross-functional team members. Accordingly, the SAM will conduct business coaching and strategy session with their account teams to facilitate the co-creation of customer value and ensure ongoing internal alignment and account growth. The SAM will function as the central focal point for communications regarding account planning, strategy, collaboration, resource allocation and customer engagement. About You Basic Qualifications Minimum required skills & experience: Bachelor's degree required 5+ years of field sales or account management experience Internal candidates with a consistent history of performance along with demonstrated capabilities or competencies may be considered with less experience. Broad understanding of health system business, decision making processes & market trends with a proven track record of accessing C-suite to D-suite decision makers Proven ability to translate health system market knowledge and develop strategic plans with internal stakeholders The ability to execute tactical initiatives, provide ongoing feedback, and prioritize multiple projects. Broad field sales experience with demonstrated success working with P&T committees, decision makers & influencers in Hospitals, Health Systems, IHNs and other large-organized customers Possesses strong business acumen and strategic thinking skills Self-directed and organized with excellent execution and planning skills Ability to adapt and change in a shifting environment Excellent communication skills both written and oral Must possess valid driver's license, be eligible for insurance coverage and must be able to safely operate a vehicle Minimum preferred skills & experience: MBA or other advanced degree Strong data analytics Experience working in Market Access, Pricing, Contracting or Finance Proficient with MS Office and customer management databases Experience leading teams with demonstrated impact & influence with key internal stakeholders Travel: Ability to travel up to 75% of the time to customers, conventions, training, and other internal meetings. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. This position is eligible for a company car through the Company's FLEET program. Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP #LI-Remote #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $122,250.00 - $176,583.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
    $45k-77k yearly est. Auto-Apply 60d+ ago
  • Sr. Predictive Maintenance Technician

    Endo 4.7company rating

    Raleigh, NC job

    Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary The Sr. Predictive maintenance technician is responsible for executing the sites predictive maintenance program. Duties include collection and analysis of vibration, ultrasound, non-destructive examination and thermographic information for plant equipment, including but not limited to fans, blowers, electrical motors, pumps, gearboxes, compressors and conveyors. Perform precision maintenance on imbalanced fans, misaligned shaft couplings, loose, or weak bases, failed bearings, worn sheaves, improper mountings and improper lubrication. Ensure all plant assets are operating at optimal levels by developing new predictive techniques and programs for plant equipment. Own the lubrication program. Identify optimal operating conditions such as load, speed and environment with the proper lubricant, application frequency, the right amount and correct sealing arrangement in order to achieve the optimum equipment life. Job Description ESSENTIAL FUNCTIONS: Works effectively with Reliability Engineers, Process Managers, and Maintenance leadership to troubleshoot and resolve equipment issues. Uses initiative to seek out root cause of failures and take steps to correct and prevent recurrences. Report on developing fault conditions and provide corrective actions and severity estimates. Coordinate with the Planning group to ensure maintenance requirements are effectively communicated. Assists in the RCFA corrective actions and helps eliminate chronic equipment issues. Schedule and execute routes and inspections to maximize productivity. Solicits recommendations from technicians and mechanics on improving existing procedures, routes, and Standard Job Plans. Assists with perform post failure analysis to verify accuracy of fault identification in order to continuously improve diagnostic skills. Reviews preliminary drawings, specifications, and plans from Engineering for accessibility for predictive and lubrication activities and recommends changes when necessary. Facilitate the maintenance department employees in receiving necessary training to maintain and improve their skill levels. Works to maximize technician flexibility through cross-training. Willingness to continue training as required to remain up to date on techniques, procedures, and practices. Effectively understand and perform IR thermography, Vibration analysis, Ultrasonic scans, and Precision laser alignments. Develop and present technical reports based on field data gathering. Generate corrective work orders in the CMMS system and assign them appropriately for planning and scheduling based on gathered data. Maintain and optimize the vibration analysis database. Performs other duties as assigned by Maintenance management and/or designee. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Other duties as assigned with or without accommodation. Assist CMMS admin with naming coordination between CMMS, P&ID's and field tags. Ability to interact with supervisors, staff, vendors, and the public using a positive collaborative approach. Ability to consistently complete assigned work while attending to multiple tasks and prioritizing projects to meet deadlines as directed. Ability to problem solve and engage necessary staff/supervisors to address emerging facility issues. Initiative and ability to work with minimal direction/monitoring; sound judgment and decision making capabilities are essential. MINIMUM REQUIREMENTS: Education: High School Diploma, GED, or equivalent required. Technical or Associate degree in a related field preferred. Experience: 5+ years experience in maintenance in a manufacturing environment. Must have a thorough knowledge of processes, equipment, and proper safety and environmental practices. Must be familiar with standard operating procedures and process documentation. Must be Vibration Data Collection and Analysis Level II certified Preferred Skills/Qualifications: Other Skills/Competencies: Certifications in infrared and ultrasonic data collection and analysis. Certification in SNT-TC-1A for UT, PT and/or MT. Must be able to effectively communicate in both verbal and written formats. Must have knowledge of basic hand tools. Knowledge of cGMP requirements. Able to plan and execute multiple projects simultaneously. Works well with new technology and computer based data gathering equipment. Must have strong computer skills (Microsoft Office, E-mail, data entry). Learn on the Fly, Organized, Self-Motivated, Action Oriented, Problem Solving RELATIONSHIP WITH OTHERS/ SCOPE: Work is routinely reviewed by site management for adherence to objectives of the site. Advises management on improvement projects and work orders, and safety or environmental hazards. Internal contacts are made on a routine basis with the first line management in the Maintenance, Production, Engineering, Utilities, Warehouse, and Quality Control areas. With the diverse interaction with numerous groups, a tactful and diplomatic approach to communications is necessary in order to achieve the cooperation between individuals and departments. Must be highly organized, self-motivated and have the flexibility to shift priorities quickly in a constantly changing work environment. WORKING CONDITIONS: The plant's open-air construction exposes employees to the normal year-round, outside climate. Some relief from the elements is available in the control rooms, offices, and break area. Dirty conditions and chemical fumes are occasionally present in the work areas. Corrosive, flammable, and toxic material, all which are normally handled in the plant, pose potential leak points for slips, trips and falls. Extra care must be taken while navigating the site. Must handle average to heavy weight materials by hand. Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, but use of proper lifting and movement techniques is necessary to prevent injury. Must be able to physically negotiate stairs and evacuation ladders, to wear and operate safety equipment, enter vessels, inspect equipment, drive forklifts. Must be able to wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
    $64k-92k yearly est. Auto-Apply 13d ago
  • QC Tech II

    Endo 4.7company rating

    Raleigh, NC job

    Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary The Quality Tech II analyzes process samples as received and performs non-routine analysis as requested. She/he will analyze finished goods and raw materials by chemical, physical, and instrumental means to ensure quality as needed. She/he will typically work on a rotating shift schedule. Job Description ESSENTIAL FUNCTIONS: Performs in process testing for internal customers. Performs finished goods, returned goods, and stability testing for external customers as needed. Performs specified analysis on all process controls samples and reports in a timely manner by telephone or computer entry using approved written procedures and proper laboratory techniques. Performs specified analysis on all finished goods using approved written procedures and proper laboratory techniques as needed. Maintains accurate and precise records of all laboratory analysis using appropriate Mallinckrodt recordkeeping system. Troubleshoots and performs routine maintenance on laboratory instrumentation. Prepares all standards and reagents needed for proper execution of analytical methods and procedures. Prioritizes and plans workload to meet all internal and external customer needs for maximum efficiency and accuracy. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Assists in any non-routine analytical work needed to solve plant problems. Works on solving problems and implementing improvements in a teaming environment. Uses problem solving skills to help with failure investigations and testing problems. Aids in performing any non-routine quality control related tasks such as resampling, raw material testing, and performing analysis needed to validate methods and equipment. Participates in a certified 5S Workplace System to ensure good housekeeping and organization. Assists with training others as needed. Other duties as assigned with or without accommodation. MINIMUM REQUIREMENTS: Education: Associates of Science (AS) or Bachelor of Science (BS) or equivalent life science degree preferred. Appropriate experience may be a suitable replacement for degree. Experience: 1 - 3 years laboratory experience in a pharmaceutical manufacturing operation preferred. Working knowledge of cGMP is a plus. Expected Skills/Qualifications: Other Skills/Competencies: Must be able to perform basic mathematical calculations. Familiarity with basic laboratory procedures, equipment, and computer key punching. Sound and correct technical judgments are required during routine analysis. High degree of concentration is required. Ability to differentiate colors, as demonstrated by passing a test designed to identify color blindness (such as the Ishihara test). If testing criteria are not met with uncorrected vision, the use of color correcting glasses may be used as long as testing criteria are met while using them. Functional/Technical Skills, Priority Setting, Written Communication Customer Focus, Organizing RELATIONSHIP WITH OTHERS/ SCOPE: Laboratory technicians are responsible for communicating any uncompleted work to the next shift, as well as any immediate priorities. Majority of work is performed independently without direct supervision. Non-routine results, observations, or analytical requests are brought to the attention of the appropriate management personnel. Reports to Quality Testing and Release Manager. Frequent interact with operators, engineers, and Quality management for reporting routine analytical results. Communication may be though radio, telephone, email, or in person. Incorrect or inaccurate analyses can result in possible shipment of reject drug items to Mallinckrodt customers. Customer-requested specifications and Mallinckrodt methods of analysis are considered confidential for marketing purposes. Ability to understand the timely nature of work, quick reporting of results, and fast changing of priorities are necessary to complete assigned tasks. Laboratory employees must be able to work effectively under these conditions. Completes all required Compliance trainings in a timely manner. WORKING CONDITIONS: Most work is performed in a well-equipped analytical laboratory complete with fume hoods, laboratory benches, analytical glassware, and instruments. Boxes of solvents, compressed gas cylinders, old records, and reserve samples are stored in areas outside the laboratory and may require lifting and transporting to the laboratory area. Exposure to fugitive emissions of chemicals typical for chemical operations. Normal dexterity is required for routine handling of laboratory glassware and instruments. Colors must be well-visualized and slight differences in volumes of liquids in appropriate glassware distinguished. Must be able to wear the required personal protective equipment (PPE), such as hard-hat, steel-toe shoes, safety glasses, and other equipment as deemed necessary by EH&S, leadership team, corporate, or safety guidelines for the position. Must be able to work a rotating12 hour shift schedule of (7pm-7am / 7am-7pm) in addition to occasional overtime as needed. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
    $29k-38k yearly est. Auto-Apply 49d ago
  • Sr. EHS Specialist

    Endo 4.7company rating

    Raleigh, NC job

    Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary SUMMARY OF POSITION: An integral member of the site EHS Department, whose primary responsibilities are to ensure a safe and healthy working environment through training, awareness, and compliance with various environmental, health, safety and security (EHSS) corporate policies, federal regulations, and other generally recognized standards and guidelines. You must possess the proper skills in order to identify hazardous workplace conditions, remove hazards and/or protect employees through development and implementation of Job Safety Analyses (JSA's) and risk assessments, in an effort to continually improve the organization's safety culture. The Sr. EHS Specialist will also assist the Environmental Engineer in the areas of air and water quality type activities as they relate to site activities and operating permits limits. You will be tasked with taking a lead role in revising and improving the site's EHS procedures and management systems. Job Description ESSENTIAL FUNCTIONS: Ensures a safe and quality working environment through training, awareness, and compliance with safety SOP's, corporate standards and OSHA regulations Assist with various EHSS inspections / audits including but not limited to state or federal agencies or required periodic 3rd party audits. Leads efforts as a team member in analyzing and continually improving the site's Safety Culture. Develops and mentors others in developing Job Safety analyses (JSA's) and risk assessments. Monitors and takes effective steps to ensure that workplace conditions comply with applicable federal and state occupational safety and health standards. Ensures that all required records are prepared and maintained. Investigates and prepares required reports on injuries and incidents. Conducts safe work procedures and other safety training courses. Provides input on equipment installation, start-up operation, and trouble shooting. Ensures accountability, transparency, and effective communication cross-functionally and within the safety team and the EHS Department while guaranteeing information is timely, clear and accurate. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Other duties as assigned with or without accommodation. Develop and apply a strong technical knowledge of Albemarle's Policies and Procedures covering Health, Safety and Environment. Other functions may include Regulatory Reporting, Employee training, and assistance contractor management. Key contributor for policy updates, creation, and implementation Document and communicate EHS Expectations, Outcomes and Metrics. Leading planning and execution of Risk Assessments and EHS Audits Required to participate in department on-call schedule. Assists with project reviews for compliance needs. Assists with Emergency Response training and response activities. Be an active member in the site's emergency response Incident Command Team Participate in continuous improvement activities and champion change when faced with adversity while incorporating team input. Supplies the highest level of internal and external customer service while having the ability to diplomatically challenge established procedures and systems. MINIMUM REQUIREMENTS: Education: B.S. degree in Occupational, Safety, and Health Engineering or related safety/technical field. Advanced degree and/or professional certification (CSP, CHMM, CIH, PE) is a plus. Experience: Minimum 5 - 10 years of experience as a EHS professional required. Previous EHS experience in a pharmaceutical, chemical, or manufacturing environment working with hazardous materials preferred. Experience in industrial hygiene monitoring activities, data interpretation and report writing. Experience with internal and external audits and inspections for regulatory compliance. Experience in developing and delivering personnel training Skills/Qualifications: Other Skills: Competencies: Must be able to walk, climb, and wear personal protective equipment (PPE) to include full body suit and respiratory equipment. Working knowledge of Title 29, Code of Federal Regulations Part 1910 and Part 1926; Working knowledge of various North Carolina Division of Environmental Quality regulations as they relate to Air Quality, Water Resources, and Waste Management. Working knowledge of various NFPA, ASME, and similar industry standards/guidelines. Skill in evaluating, planning (including strategic planning), organizing and reviewing regulations to determine compliance with various federal regulatory requirements and corporate EHS policies. Ability to prepare and communicate technical data for use by a variety of different audiences, such as the Site Leadership, supervisors, senior engineers/scientists, technical expert, and operators. Ability to use safety management and engineering practices for the continuous improvement of Plants TRR and workers compensation rates. Excellent communication, interpersonal and technical writing skills. Strong interpersonal skills. Ability to handle multiple priorities. Detail-oriented with the ability to work under tight deadlines. Decision making, problem solving and analytical skills. Conflict management skills. Strong proficiency in Microsoft Office applications required.. Knowledge of FDA's Good Management Practices (cGMP) Ability to effectively communicate with all levels of the organization, from operations to senior management, both oral and written format. Action Oriented, Drive for Results, Problem Solving, Timely Decision Making, Written Communications, Process Management, Time Management, Organizing RELATIONSHIP WITH OTHERS/ SCOPE: This position reports to the EHSS Manager. The Sr. EHS Specialist supports the EHSS goals and functions of the pharmaceutical manufacturing facility. This position interacts with all levels of the facility from production operators to senior site leadership. Ability to effectively interact with manufacturing, maintenance, and medical departments. WORKING CONDITIONS: This position works both in the office and plant setting, both indoors and outdoors. Outdoor conditions will include the temperature and weather extremes. Work outside of normal business hours may be required including working early, staying after normal working hours, weekend work, or holiday work. This position will rotate on-call duties, which include weekend/holiday coverage of plant operations. Physical demands of this job include climbing stairs and extensive periods of walking and standing. Exposure to fugitive emissions of chemicals typical for chemical operations. Must be able don required personal protective equipment (PPE), such as hard hats, safety glasses, safety shoes, flame resistant clothing, respiratory protection, chemical protective suit, etc., as deemed necessary by EHS. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
    $46k-64k yearly est. Auto-Apply 5d ago
  • Therapeutic Specialist Tzield, Raleigh, NC

    Sanofi Us 4.3company rating

    Raleigh, NC job

    Job title: Therapeutic Specialist Tzield, Raleigh, NC About the Job Therapeutic Specialist, Tzield are part of the National Tzield Sales Team and play a pivotal role in bringing a paradigm-shifting Type 1 Diabetes product to market. Therapeutic Specialists leverage their deep sales experience and expertise to accelerate Tzield adoption across providers and accounts and collaborate closely with all respective cross-functional partners. This role will develop territory-specific sales strategies, educate endocrinology and primary care providers on both Tzield and screening, and build a robust Tzield customer base. We are an innovative global healthcare company with a focus on immunology that extends to innovation in diabetes and transplant medicine. Across different countries, our talented teams are determined to deliver a best-in-class customer experience using the best of digital, artificial intelligence and personal know-how. With a focus on immunology that extends to innovation in diabetes and transplant medicines, we pursue progress to make a real impact on millions of patients around the world. Join the team transforming how healthcare is delivered for chronic and specialty conditions worldwide. In General Medicines, you'll help drive meaningful outcomes in diabetes, transplant, and immunology - with the scale and urgency patients deserve. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities Brand Awareness & Intent to Treat with Endos. Build belief in Tzield mechanistic rationale and clinical narrative (e.g., MOA involving beta cell preservation, approved indication, efficacy / safety profile). Develop in-depth knowledge and understanding of key accounts across territory, including barriers to Tzield use. Contribute to priority account strategy development lead by SAMs and own execution to engage endocrinology and primary care providers on Tzield use. For non-priority Endo in territories, own the development and execution of growth-oriented account & business plans (e.g., account mapping, influence mapping, etc.). Identify account champions / KOLs and engage them as necessary and appropriate to communicate with peers and patients about Tzield. Screening Awareness & Development of T1D Ecosystem. Build belief in T1D early detection and importance of screening for T1D in asymptomatic, undiagnosed, early detection population. Conduct strategic planning at territory level to understand and contribute to development of broader T1D ecosystem in order to prioritize time, engagement, and education strategy. Contribute to screening strategy development and own execution to engage PCP / Ped on early detection & screening. Collaborate with stakeholders to identify and educate on importance of urgent referrals for identified patients within narrow treatment window. Educate relevant stakeholders on at-risk populations, screening / monitoring best practices, and the value of early detection (e.g., DKA avoidance). Additional Responsibilities Collaborate closely with cross-functional Sanofi teams to support customers. Attending local, regional, and national meetings as directed. Maintaining strict adherence to all legal, regulatory, ethical, administrative, and financial duties. Achieving and exceeding assigned monthly, quarterly, and annual sales quotas. About You Qualifications B.A. / B.S. degree required. 3+ years of pharmaceutical, biotech or medical device sales experience. Account Management sales and / or rare specialty product experience. Demonstrated ability to understand and use data to drive improved business management and oversight of the sales within customer territories. Proven results of increasing educational awareness, provider adoption and customer engagement. Experience successfully launching products in the field. Experience collaborating and working in a matrix environment across multiple different sales, medical and support functions. Strong business acumen and solution-oriented mind-set Ability to strategically plan and execute work. Robust communication skills and ability to engage in two-way stakeholder dialogue. High accountability for all feedback, coaching, and results Valid driver's license. Ability to travel up to 80% of the time to customers, conventions, training, and other internal meetings. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Help shape the future of care for chronic and complex conditions like aT1D, Type 2 diabetes, transplant, and cardiovascular disease. Be part of a simpler, digital- and AI-powered business that's rethinking how we work and engage with the world. Drive meaningful impact at global scale: our medicines reach more than 100 million people each year. Contribute to innovations that improve outcomes, relieve pressure on healthcare systems, and expand access worldwide. This position is eligible for a company car through the Company's FLEET program. Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA #LI-Remote #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $125,250.00 - $180,916.66 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
    $25k-33k yearly est. Auto-Apply 12d ago
  • Manager Quality Control

    Endo 4.7company rating

    Raleigh, NC job

    Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary The Quality Control (QC) Manager serves as a Quality Control technical resource to the plant. She/he is the primary point of contact for the testing of all raw materials, in-process, finished goods, and stability samples. She/he manages the Quality Control group and compliance activities to achieve key site and corporate objectives. The Quality Control Manager is responsible for overseeing all QC activities to ensure pharmaceutical products meet regulatory requirements and internal quality standards. This role involves managing QC laboratories, supervising testing processes, and ensuring compliance with Good Manufacturing Practices (GMP) and applicable regulations (FDA, EMA, ICH). This individual will provide overall QC leadership regarding cGMP compliance concerns and improvements, as well as manage budget line items, overtime, efficiency improvements, and staffing. Job Description ESSENTIAL FUNCTIONS: Develop and implement QC policies, SOPs, and testing protocols in compliance with GMP and regulatory guidelines. Oversee analysis of raw materials, in-process samples, and finished products to ensure they meet specifications. Ensure adherence to FDA, EMA, and other regulatory standards, including PIC/S GMP requirements. Maintain accurate records of all QC activities, including test results, deviations, and corrective actions. Manage and train QC staff, assign tasks, and monitor performance to maintain high standards of quality. Identify quality issues, perform root cause analysis, and implement corrective and preventive actions (CAPA). Prepare for and participate in internal and external audits, including regulatory inspections. Oversee calibration, validation, and maintenance of laboratory instruments. Provides subject matter assistance for LIMS, methods, testing, and validation. Manages QC testing group to achieve compliant testing in a timely manner. Manages Lab investigations and OOSs including remediation of potential compliance concerns. Provides overall leadership to QC group regarding cGMP compliance improvement and enhancement. Studies and improves various Quality processes providing increased efficiency or process flow using Lean Manufacturing and/ or Six Sigma philosophy of operation. Drives Quality consistency through reviewing/revising various analytical methods/SOPs to ensure adequacy with special emphasis on actual utility of methods under normal QC conditions. Works with plant Managers/Supervisors and Quality technicians to address any laboratory concerns regarding quality, safety, methods, procedures, or operations. Acts as a liaison between the lab and manufacturing/ R&D for investigations and to implement special projects, assist with validations, method transfers, or technology upgrades. Works with groups to ensure compliance to EHS and departmental safety requirements and provide proactive leadership toward continuous improvement of safety operations in the laboratory. Ensures key turnaround timelines for customer service and compliance requirements are achieved. Performs as a subject matter expert during customer and regulatory audits. Work closely with Production, R&D, and Quality Assurance teams to ensure product quality throughout the lifecycle. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Develops and coaches to build talent. Participate in a 5S Workplace System to ensure good housekeeping and organization. Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy. Effectively trains others in a positive manner. Other duties as assigned with or without accommodation. MINIMUM REQUIREMENTS: Education: B.S. /B.A. in Physical Science required. Master's Degree preferred. Experience: 10 - 12 years related experience preferred; at least five years of experience in a supervisory role; strong knowledge of current pharmaceutical cGMP requirements Preferred Skills/Qualifications: Other Skills/Competencies: Complete understanding and application of principles, concepts, practices, and standards for testing performed in all QC laboratories Experience with testing API or Pharma products Experience leading a group of up to 20 people with 24/7 shift operations Excellent written and verbal communication and leadership skills Ability to work in and promote a team environment Working knowledge of Six Sigma and/or Lean manufacturing tools Sense of urgency. Action oriented/drives for results Excellent communication and interpersonal skills Team orientation/strong team player Ability to coach, mentor and teach Excellent decision making, problem solving and analytical skills Strong managerial courage Ability to influence change at all levels of the organization Detail-oriented with the ability to work under tight deadlines Excellent conflict management skills Builds positive relationships with others Excellent time management and prioritization skills Excellent technical writing skills LIMS experience preferred Knows the difference between managing and leading and when to apply each Command Skills, Action Oriented, Conflict Management, Customer Focus, Problem Solving, Priority Setting, Written Communication, RELATIONSHIP WITH OTHERS/ SCOPE: Reports to Site Quality Director Work is performed without appreciable direction Develops strategic objectives for group managed Exercises considerable latitude in determining technical objectives of assignment Completed work is reviewed for desired results from a relatively long-term perspective Bias toward change, management of change, and achievement of results Contact with FDA as subject matter expert during site inspections and customers during frequent customer audits Regular contacts include Quality Assurance, Materials Management, Logistics, Commercial, R&D, Site Production Leaders and EH&S. This position has several direct reports WORKING CONDITIONS: 60% normal office and meeting room conditions. 40% Laboratory and Plant environment including exposure to raw materials and finished products. Must be able wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines. Some off shift and weekend work can be expected; travel requirements are minimal DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
    $82k-113k yearly est. Auto-Apply 60d+ ago
  • Maintenance Pipefitter

    Endo Pharmaceuticals Inc. 4.7company rating

    Raleigh, NC job

    Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary We are seeking a skilled and safety-focused welder to join our team. The ideal candidate will have proven experience in pipe and plate welding along with metal fabrication. S/he has ability to interpret blueprints, project plans, and isometric drawings to complete pipe fitting and welding tasks. S/he must be able to accurately pre-fab and install pipe replacements and upgrades. This role requires strong technical knowledge, attention to detail, and the ability to collaborate with construction and maintenance teams to ensure safe, high-quality project execution. Job Description Blueprint and Drawing creation and interpretation Create, read, and interpret project plans, blueprints, piping diagrams, and isometric drawings. Translate written instructions and diagrams into precise fabrication and installation tasks. Fabrication and Installation Measure, cut, thread, groove, bend, and weld pipes according to specifications. Prefabricate piping systems and confirm alignment, tolerances, and fit prior to installation. Assemble pipes, fittings, and valves using appropriate tools, equipment, and joining techniques. Understanding and experience with carbon steel, stainless steel (304L & 316L), aluminum, and alloy 20 metals, among others. Ensure accurate pipe fit-up and compatibility with structural components. Repair equipment in the field, as needed, including within confined spaces. Testing and Quality Control Inspect and test completed piping systems for leaks, durability, and compliance with industry standards. Identify issues, perform adjustments, and report malfunctions or defects to supervisors. Ensure adherence to project specifications, codes, and safety regulations. Collaboration and Teamwork Work closely with welders, fabricators, and construction crews to ensure seamless project integration. Participate in failure analysis and troubleshooting to address causes of equipment or system failures. Communicate effectively with supervisors, engineers, and team members. Safety and Compliance Support and follow all site safety programs, policies, and guidelines. Wear and maintain all required Personal Protective Equipment (PPE), including full-face respirators, hard hats, safety glasses, gloves, steel-toe boots, and chemical-resistant gear when necessary. Contribute to a safe work environment by practicing proper housekeeping in the shop and on job sites. Equipment and Maintenance Operate and maintain pipefitting machinery and tools (cutting torches, threading machines, grinders, calipers, etc.). Ensure equipment is used safely and kept in good working condition. Report any equipment malfunctions promptly. Requirements Minimum of 2 years' proven experience as a Pipe Fitter. Strong ability to read and work from blueprints, isometric drawings, and piping diagrams. Skilled in pipe fabrication, alignment, and installation processes. Familiarity with welding processes and ability to collaborate with welders during fit-up and installation. Proficiency in using tools and equipment such as cutters, threading machines, torches, squares, and calipers. Ability to pass fit-up or pipefitting assessments as required. Strong attention to detail with a results-driven and safety-focused approach. Physical ability to stand, bend, squat, and lift heavy materials regularly. Must be able to work in varying environmental conditions (indoor/outdoor, hot/cold, confined spaces). Commitment to workplace safety and compliance with all PPE requirements. Preferred Qualifications Experience working on industrial, commercial, or construction piping systems. Knowledge of relevant codes and standards (ASME, ANSI, OSHA, etc.). Ability to weld pipe and plate using GTAW and SMAW methods when required. Demonstrated teamwork and communication skills in a construction or industrial setting. Ability to perform basic NDE techniques, such as visual examination and liquid dye penetrant examination. Work Environment This position involves work in both shop and field settings. Candidates must be able to adapt to changing work environments, including exposure to noise, dust, extreme temperatures, and confined spaces. Pipe Fitters must also be able to work at heights and in physically demanding conditions while maintaining strict adherence to safety standards. Shop and industrial manufacturing areas without climate control. Must be able to go up and down several flights of steps on occasion. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
    $54k-80k yearly est. Auto-Apply 60d+ ago
  • Specialist, Quality Assurance for QC

    Astellas Pharma 4.9company rating

    Sanford, NC job

    Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Purpose and Scope: The Specialist, Quality Assurance for QC will be responsible for providing direct Quality oversight and support for Quality Control and US Methods and Tech Transfer laboratory operations and method qualification activities. This role will ensure adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures. This role will collaborate with cross-functional teams such as other Quality Assurance, Validation, Manufacturing, and MSAT teams to ensure quality and compliance. Essential Job Responsibilities: Quality Oversight of Laboratory Operations: Provide QA oversight of QC laboratory activities, including testing of raw materials, in-process samples, drug substance and drug product, and environmental monitoring. Conduct routine area walkthroughs to ensure laboratories operate in a state of control and comply with current Good Manufacturing Practices (cGxP). Test Method and Material Lifecycle Management: Oversee the qualification, validation, and transfer of analytical methods, critical reagents, and reference standards. Review and approve associated protocols, reports, and deviations to ensure compliance with regulatory and internal standards. Technical Leadership and Support: Serve as a Subject Matter Expert (SME), providing advanced technical guidance and troubleshooting support for complex laboratory and quality-related issues. Make informed decisions with minimal guidance, proactively seeking input when addressing cross-functional challenges. Assist in workload management by prioritizing and distributing tasks across the team to ensure efficient execution of responsibilities. Data and Documentation Review: Review and authorize laboratory testing data within Laboratory Information Management Systems (LIMS). Review and approve Certificates of Analysis (CoA) and Certificates of Testing (CoT) to support batch disposition. Review and approve Product Specification documents to ensure alignment with regulatory and internal requirements. Quality Systems and Compliance: Lead or support nonconformances and deviations related to QC processes, including laboratory investigations, Out of Specification (OOS), and Out of Trend (OOT) results. Author, review, and approve controlled documents such as Standard Operating Procedures (SOPs), specifications, protocols, and reports for Quality and GMP-related functions. Author, review, and approve Quality System records, including Nonconformances, Corrective and Preventive Actions (CAPAs), and Change Management documentation, with thorough causal and impact assessments.
    $48k-73k yearly est. 1d ago
  • Maintenance I/E Technician

    Endo 4.7company rating

    Raleigh, NC job

    Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary SUMMARY OF POSITION: The Maintenance I/E Technician performs a variety of electrical and instrumentation duties involving the maintenance of plant facilities. S/he will be responsible for calibrating, installing, maintaining, repairing, and inspecting plant monitoring devices on a wide variety of complex digital, analog, programmable, and other auxiliary equipment. Job Description ESSENTIAL FUNCTIONS: Installs, troubleshoots, repairs, and calibrates low voltage AC/DC electrical and instrumentation controls as well as 3-phase 480-volt power circuits. Interfaces with OEM's and vendors as necessary. Requisitions equipment as needed. Accurately completes all work performed according to standard operating procedures (SOPs) and work instructions, including proper documentation. Completes work orders using CMMS (Maximo) system. Performs repairs and modifications as directed by maintenance supervisor, or other plant management. Supports and participates in training programs. Keeps the maintenance supervisor abreast of job status. Supports site safety programs. Supports/leads failure analysis process by discussing the causes of equipment failure with the maintenance supervisor, or the maintenance engineer. Accurately completes all required paperwork, including but not limited to timesheets, “found as-left” forms, calibration reports (ICIR), and PM checklists. Responsible for good housekeeping in the shop and at the job site. Must be able to wear the required Personal Protective Equipment (PPE), full face respirator, hard hats, safety glasses, ear plugs, goggles, boots, steel -toe shoes, gloves, chemical resistant aprons and suits, and other personal protective equipment deemed necessary by EHS, leadership team, corporate, or safety guidelines for each job task. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Other duties as assigned with or without accommodations. Supports the PM/PdM program and calibration program by ensuring a high quality of workmanship. Accurately enters all required information on work orders. Assists the maintenance supervisor and maintenance engineers, or others as needed with equipment installation, maintenance, repair techniques, and with identifying opportunities for improving equipment reliability. Shows emphasis on the design, installation, commissioning, maintenance, and use of mechanical equipment throughout the facility. Recognizes problem independently and troubleshoots malfunctioning equipment without direct supervision. MINIMUM REQUIREMENTS: Education: High School diploma, GED, or equivalent. Associate or Technical degree in a mechanical field preferred. Experience: 1 - 3 years I/E experience in a pharmaceutical manufacturing operation. Preferred Skills/Qualifications: Skills/Competencies: Other Skills: Work as an industrial I/E mechanic, PLC skills. Must have a working knowledge of the tools and test equipment used for testing, calibrating, repairing, and maintain production instruments and controls. Must be able to read and comprehend blueprints, electrical schematics, and engineering specifications. Must be able to perform shop math. Must be able to understand electricity, respect, and follow safety guidelines. Must be able to read and follow written instruction. Should be familiar with National Electrical Code, NFPA 70E, calibration standards, and cGMP. Experience working with voltages up to 480. Experience with CMMS, such as MP2 or Maximo. Learning on the Fly, Problem Solving, Interpersonal Savvy RELATIONSHIP WITH OTHERS/ SCOPE: Reports to Maintenance Supervisor. Utilizes a variety of test instruments, hand tools, supplies, and other shop equipment on a daily basis. On occasion, it may be required to take tools to the work area in the plant. No direct responsibility exists for the works of others, although adherence to the team concept requires mutual assistance in some jobs. Indirectly responsible for amount and quality of product through the maintenance and repair of production equipment. A thorough understanding of cGMP is critical. Significant responsibility for the safety of others, improperly repaired equipment could possibly result in safety hazards to plant personnel. Understands the misuse of processing equipment could result in serious injuries to self and others due to the potentially dangerous nature of the equipment and the chemicals being processed. WORKING CONDITIONS: I/E Technicians are required to work in all areas of the plant site, both inside and outside. There may be exposure to warm areas, dirt, oil, grease, chemicals/chemical fumes, and noise. Injuries could result from spills or leaks or corrosive, flammable, and toxic material, all which are normally handled in the plant. Dangers, such as sharp edges, pinch points, chemical and temperature burns, lifting, and electricity are often present. Personal protective equipment required to be worn often. Routinely lifts and carries objects of 50 pounds or less in weight. Must be able to go up and down several flights of steps on occasion. May be required to exert effort to pull control valves, loosen bolts, or move controls and instrumentations. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
    $53k-74k yearly est. Auto-Apply 60d+ ago
  • Area Business Manager, Dermatology, Raleigh, NC

    Sanofi Us 4.3company rating

    Raleigh, NC job

    Job title: Area Business Manager, Dermatology, Raleigh, NC About the Job Sanofi focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. Sanofi has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases, oncology, immunology, and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Sanofi's portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. At Sanofi, we are committed to the growth of our people, connected in purpose by career, life and health. The Area Business Manager (ABM) is responsible for engaging Dermatologists and other key customers within an assigned geography and presenting clinically focused selling messages to create and grow revenue and to consistently deliver product goals related to Atopic Dermatitis, Prurigo Nodularis, CSU and BP. The ABM will demonstrate initiative, drive, independence, and take ownership for meeting and exceeding individual business goals. This will be accomplished by driving performance and delivering results in a compliant manner with a high degree of integrity strictly following all Sanofi US policies and in compliance with all policies and procedures governing the promotion of pharmaceutical/biological products in the US. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Specialty Care, you'll help deliver breakthrough treatments that bring hope to patients with some of the highest unmet needs. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities: Engage Dermatology/Immunology customers within assigned geographical territory and deliver clinically focused message to introduce, launch, grow brand-share and revenue and to consistently deliver on product goals for atopic dermatitis and other dermatological indications. Collaborate and coordinate with other key field-based stakeholders such as Regeneron Sales Professional counterparts, Medical Science Liaisons, Field Reimbursement and Market Access teammates, Thought Leader Liaisons, and others in their territory to proactively address customer needs, identify market dynamics and trends, develop strategies which support brand and corporate objectives, and ensure optimal account success within their assigned geography. Develop strong working relationships with Dermatology experts in assigned geography as well as biologic coordinators, office staff and other important health care personnel and key patient advocacy support groups as directed. Drive results by identifying key opportunities and developing strategic business plans to generate product utilization and grow territory business. Plan, organize, and execute local promotional speaker programs and activities. Maximize budget allocated to the geographic territory to support execution of strategies and tactics and generate/grow the business. Participate and help lead initiatives to support sales success as assigned (e.g. participate in industry related congresses, local and regional meetings and medical conferences). Own business opportunities within respective geographic area, which includes coordination and calling upon large group practices and other key targets to drive overall product results. Establish relationship with thought leaders in assigned territory. Primary objective is to drive industry leading customer value. About You Basic Qualifications: Bachelor's degree from an accredited four-year college or university. 3+ years of pharmaceutical, biotech, or medical device sales experience. Demonstrated ability to learn and apply technical and scientific product-related information. Ability to travel to meetings/trainings/programs as necessary - additional travel may be required within the assigned territory. Proven success and positive track record of consistent sales performance in complex markets with diverse customer segments operating with a high degree of integrity within compliance guidelines. Ability to operate as a “team player” in cooperation with collaboration partners and internal colleagues to reach common goals. Valid Driver's License. Preferred Qualifications: 2+ years selling sub-cutaneous self-injectable (or office administered IV) biologics in a complex and competitive market. 2+ years selling experience in dermatologic disorders such as atopic dermatitis strongly preferred. 2+ years selling experience calling on Dermatologists. Launch experience in specialty care and biologics strongly preferred. Alliance/matrix partnership experience strongly preferred. Demonstrate advanced clinically based selling skills. Results oriented with a proven track record of success with product launches. Experience with in-servicing and training office staff, nurses and office managers. Demonstrate a passion and learning aptitude for science and is proactive in strengthening knowledge related to disease-state, treatment options and healthcare trends. Highly organized with strong account management skills. Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents. This position is eligible for a company car through the Company's FLEET program. Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Remote #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $125,250.00 - $180,916.66 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
    $125.3k-180.9k yearly Auto-Apply 15d ago
  • Clinical Development Lead - Raleigh

    UCB 4.3company rating

    UCB job in Raleigh, NC

    Make your mark for patients We are looking for a Clinical Development Lead to join us in our Clinical Development team, based in any of our Brussels (Belgium), Monheim (Germany), Slough (UK) or Atlanta/Raleigh (US) offices. About the role As a Clinical Development Lead, you have the opportunity to leave a lasting impact on patients' lives by driving innovative, patient-centric clinical strategies in a highly visible, high-stakes environment. Reporting to senior R&D leadership, you will lead the end-to-end design and execution of global development programs, working cross-functionally to translate science into access, and strategy into action. Who you'll work with You'll collaborate with global thought leaders, guide multifunctional teams, and influence decisions that shape both science and the business. You will report into the Global Head of Clinical Development for Immunology What you'll do Set the global clinical development strategy for assigned asset(s), ensuring alignment with TPVP, regulatory requirements, and commercial goals. Lead external engagement with global thought leaders, investigators, and stakeholders to continuously refine strategy based on emerging insights and unmet needs. Design and adapt robust clinical development plans that integrate the latest scientific, regulatory, operational, and payer perspectives-balancing innovation with executional feasibility. Oversee the execution of pivotal studies and regulatory submissions across all relevant markets, ensuring clinical excellence, data integrity, and timely delivery. Shape clinical narratives and regulatory strategy, acting as a key representative in interactions with global health authorities and strategic partners. Contribute to corporate strategy, supporting business development initiatives and representing the clinical perspective in asset evaluations. Interested? For this position you'll need the following education, experience and skills: Basic Requirement: Advanced degree (MD, PhD, PharmD, or equivalent). Preferred Requirements: Track record of leading complex global programs across multiple indications. Familiarity with digital health technologies, real-world data, and AI-enabled trial innovation. Ability to lead through ambiguity, make informed decisions in uncertainty, and drive results across organizational boundaries. Strategic mindset with a bias for innovation, speed, and operational excellence. Exceptional communication and stakeholder management skills, including C-suite level. Global experience and cultural fluency; willingness to travel internationally as needed. *This position's reasonably anticipated base salary range is $274,000-$359,600 annually. The actual salary offered will take into account internal equity and may also vary depending on the candidate's geographic region, job-related knowledge, skills and experience, among other #TeamUCB Are you ready to ‘go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you! About us UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science. Why work with us? At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential. At UCB, we've embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office. UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
    $101k-141k yearly est. 60d+ ago
  • Specialist, Quality Engineer

    Astellas Pharma 4.9company rating

    Sanford, NC job

    Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Purpose and Scope: The Specialist, Quality Engineer will provide input and oversight to ensure compliant operations are effectively established and maintained through implementation, execution, and assessment of quality systems, procedures, and records to support compliant GMP operations. The Specialist, Quality Engineer will be tasked with performing a wide variety of activities to ensure that Astellas Quality requirements are being fulfilled through adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures. This position works closely with Manufacturing, Engineering, Facilities, Document/Data Management, Quality Assurance, Quality Control and other GxP supporting functions to ensure compliance. Essential Job Responsibilities: Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance to SOPs and relevant Good Regulated Practice (GxP) requirements. Perform operations ancillary documentation review/approval, including but not limited to logbooks, work request, etc. Perform Quality oversight of calibration and maintenance programs within the CMMS Provide Quality oversight of the facility EMS program. Provide Quality oversight of Facility programs such as pest control and access control. Provide Quality review and approval of Engineering drawings within the Engineering EDMS. Author, review, and approve controlled documents for the Quality organization and other GMP functional areas including SOPs, protocols, and reports. Quality oversight to ensure documentation generated meets internal policy, procedures and regulatory expectations. Author, execute, review, or approve Quality Management System records, including but not limited to non-conformances and change controls. May facilitate risk assessments with cross functional teams in support of projects, programs or Quality System Records. Define, track, and report quality metrics relevant to job responsibilities. Assist in the preparation and hosting of regulatory (e.g. FDA, EMA, DHHS, etc.) inspections as needed. May perform other quality assurance activities and responsibilities as assigned.
    $61k-80k yearly est. 1d ago
  • Maintenance Mechanic

    Endo International 4.7company rating

    Raleigh, NC job

    **Why Us?** At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. ** Summary** The Maintenance Mechanic performs a variety of mechanical tasks to install, maintain, repair, and troubleshoot plant equipment and site facilities. **Job Description** **ESSENTIAL FUNCTIONS** **:** + Installs, troubleshoots, and repairs process equipment, which includes hydraulic, pneumatic and mechanical systems to include pumps, gear reducers, fans, centrifuges, boilers, compressors, vacuum systems and a wide variety of facility equipment in a GMP environment. + Interfaces with OEM's and vendors as necessary. Requisitions equipment as needed. + Accurately completes all work performed according to standard operating procedures (SOPs) and work instructions (WIs), including proper documentation. Completes work orders using CMMS (Maximo) system. + Performs repairs and modifications as directed by Maintenance Supervisors and Plant Management. + Supports and participates in training programs. + Keeps the Maintenance Supervisors abreast of job status. + Supports site safety programs. + Supports/leads failure analysis process by discussing the causes of equipment failure with maintenance technicians, maintenance supervisors or the maintenance engineer. + Responsible for good housekeeping in the shop and at the job site. + Must be able to wear the required Personal Protective Equipment (PPE), full face respirator, hard hats, safety glasses, ear plugs, goggles, boots, steel -toe shoes, gloves, chemical resistant aprons and suits, and other personal protective equipment deemed necessary by EHS, leadership team, corporate or safety guidelines for each job task. **DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:** + Other duties as assigned with or without accommodations. + Supports the PM/PdM program by ensuring a high quality of workmanship. + Accurately enters all required information on work orders. + Assists Maintenance Supervisors and Maintenance Engineers and others with equipment installation, repair techniques and identifying opportunities for improving equipment reliability. Show emphasis on the design, installation, commissioning, maintenance and use of mechanical equipment throughout the facility. + Recognizes problems independently and troubleshoots malfunctioning equipment without direct supervision. **MINIMUM REQUIREMENTS** **:** _Education:_ High School diploma, GED or equivalent. Associate or Technical degree in a mechanical field preferred. _Experience:_ 1 - 3 years mechanical experience in a pharmaceutical manufacturing operation. _Preferred Skills/Qualifications:_ _Skills/Competencies:_ _Other Skills:_ Welding skills. Shaft Alignment Precision Maintenance Lubrication Mechanical Seals Pumps- Multiple types (Centrifugal, positive displacement, etc) Gearboxes Torque and its application Must have knowledge of basic hand tools. Must be able to perform basic math. Must be able to read measuring tape, calipers and blueprints. Must be able to read and follow written instruction. Experience with a CMMS such as MP2 or Maximo. Learning on the Fly, Problem Solving, Interpersonal Savvy **RELATIONSHIP WITH OTHERS/ SCOPE:** + Reports to the Maintenance Supervisor. + Utilizes a variety of test instruments, hand tools, supplies and other shop equipment on a daily basis. + No direct responsibility exists for the works of others, although adherence to the team concept requires mutual assistance in some jobs. + Indirectly responsible for amount and quality of product through the maintenance and repair of production equipment. A thorough understanding of cGMP is critical. + Understands the misuse of processing equipment could result in serious injuries to self and others due to the potentially dangerous nature of the equipment and the chemicals being processed. **WORKING CONDITIONS:** + Technicians are required to work in all areas of the plant site, both inside and outside. There may be exposure to warm areas, dirt, oil, grease, chemicals/chemical fumes and noise. + Injuries could result from spills or leaks or corrosive, flammable and toxic material, all which are normally handled in the plant. + Dangers such as sharp edges, pinch points, chemical and temperature burns, lifting and electricity are often present. Personal protective equipment required to be worn often. + Routinely lifts and carries objects of 50 pounds or less in weight. Must be able to go up and down several flights of steps on occasion. May be required to exert effort to pull control valves, loosen bolts or move controls and instrumentations. + May be required to wear a full-face respirator contingent upon required job duties. **DISCLAIMER** **:** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. **EEO Statement:** We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
    $34k-49k yearly est. 7d ago
  • Chemical Process Engineer

    Endo 4.7company rating

    Raleigh, NC job

    Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary Summary SUMMARY OF POSITION: The Production Engineer will function as a part of the APAP Operations Team. The Production Engineer will apply technical skills to manage day-to-day production, optimize plant operation, resolve operational issues, and investigate process deviations. The Production Engineer will provide technical assistance to the APAP manufacturing employees to ensure that production targets are met while complying with all applicable Safety and Quality rules and regulations Job Description ESSENTIAL FUNCTIONS: Studies process and equipment to identify problems and opportunities. Provides technical guidance and instruction to APAP Operations Team regarding troubleshooting and debottlenecking efforts. Ensures that all processes operate within defined and validated limits. Conducts training for APAP Operations Team on new equipment and process changes. Represents the APAP Operations Team in developing and implementing capital projects. Activities include project scoping, operating requirements, process controls, process tolerances, alarm rationalization, and validation. Prepares periodic reports that summarize production rate, yield, rework status, quality condition and that summarize any special projects or problems that have been encountered. Identifies and implements changes to reduce product cost by increasing production rate, improving yield, reducing downtime, improving equipment efficiency, etc. Participates in periodic process audits with management personnel with respect to safety, environmental, quality, production, and cost. Generates, reviews, and updates documentation for managing the process, including operating reports, batch records, P&IDs, etc. Reviews operating reports and batch records for accuracy and improvements. Participates in customer and regulatory audits. Investigates process deviations, inquiries, complaints and equipment loss incidents and identifies corrective and preventative actions where needed. Coordinates implementation of corrective measures. Actively supports site continuous improvement process and serves on teams as needed to improve the workplace and increase efficiency and productivity. Other duties as assigned with or without accommodation. MINIMUM REQUIREMENTS: Education: Must have a B.S. in Chemical or Mechanical Engineering Experience: Must possess knowledge of chemical and chemical engineering principles in order to solve production, quality and throughput problems. 1-5 years of experience in chemical or bulk pharmaceutical (API) manufacturing operations Preferred Skills/Qualifications: Other Skills: Competencies: Understanding of GMPs (ICH Q7) and process validation Understanding of Six Sigma and Lean Manufacturing tools and concepts Experience in root cause analysis Experience with change control / management of change Demonstrated technical and leadership skills including oral/written communications, conflict resolution, decision making and sufficient financial acumen to interpret cost analyses and other reports Ability to plan and execute tasks on multiple projects simultaneously Must strive for continuous improvements in all work activities Self-motivated, Action-oriented, Technical Skills, Problem Solving, Informing, Organizing RELATIONSHIP WITH OTHERS/ SCOPE: The Production Engineer will report to the APAP Focus Factory Manager The Production Engineer will work closely with the other APAP Sr. Production Engineers, Supervisors and Sr. Day Operator to coordinate tasks Frequent interactions with the following functions will be required: APAP production operators QA and QC Maintenance and Engineering EHS Periodic interaction/communication with all site departments and corporate groups May work with outside engineering design firms, manufacturer's representatives, vendors, and construction contractors WORKING CONDITIONS: Works in an office environment, but will spend significant time in a multi-story bulk pharmaceutical (API) manufacturing plant that is partly outdoors May be exposed to fugitive emissions of chemicals typical of chemical operations Must be able to climb stairs and ladders for equipment installation review, monitoring and troubleshooting. Must be willing and able to wear PPE including hard-hat, steel-toed shoes, safety glasses, earplugs, fire-resistant clothing and any other devices or equipment that may be required Position is required to be periodically available for on-call nights/weekends DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
    $86k-118k yearly est. Auto-Apply 60d+ ago
  • Warehouse Operator

    Endo International 4.7company rating

    Raleigh, NC job

    **Why Us?** We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. ** Summary** The Warehouse Operator will be assigned to the shipping floor /general warehousing areas. S/he is responsible for daily duties of shipping finished goods and handling inventory by executing instructions issued by the Shipping and Receiving Supervisor, and continuously improving cGMP environment. Executes customers' orders to meet and exceed their expectations in a safe, efficient and timely manner while upholding the high standards of the company and complying with all company policies. The Warehouse operator may, from time to time, be called upon to support the Receiving group. **Job Description** **ESSENTIAL FUNCTIONS** **:** The Operator will be assigned the positions of Picker, Packer, Loader, or Rover on a rotating weekly basis. S/he will be accountable for the performance of each position's duties as assigned for the week. Picker + Lead morning exercises. + Picks, set down and stage products in accordance with the daily plan, available staging area and the picking ticket. + Visually inspects pallets during set down and mark any damaged pallets or products observed. + Ensures a minimum of two orders are fully set down at all times during the business day, one being loaded, and one being packed. Seeks support from the Rover to achieve this duty when needed. + Marks/identifies each order with cone markers. + Group lots together as picked. Places a marker at any change in lots and identify mixed lot pallets. + Keeps all documents attached to clip boards and keeps clip boards in designated area with the order. + Ensures a minimum of 1 ½ loads are set down at the end of the day. + Completes all required shipping documents including standard operating procedures (SOPs). + Supports teammates as needed.Packer + Inspects all drums, bags, pallets, slip sheets and identify. Corrects or rejects any defect in accordance with SOPs. + Labels and/or marks all products and pallets as required. + Cleans, adjusts, changes pallets and applies any special packing requirements in final preparation before wrapping. + Ensures only drums assigned to the order are packed and any restricted or rejected drums not included. + Scans or checks off all items in completion of packing an order and issues a "No Errors" report. + Ensures one order is completely packed and ready for loading before the last pallet of the preceding order is loaded. + Ensures one order is completely packed and ready for loading the next day. + Seeks support from the Rover when an order may not be prepared in time for the Loader team. + Completes all required shipping documents including SOPs. + Keeps all documents attached to clipboards and keep clipboard in designated area with the order. + Keeps bags and drums free from foreign materials. + Reports damaged containers within one hour of discovery. + Supports teammates as needed. Rover + Empties trash cans and dumpster daily. + Submits inventory supply list weekly. + Completes 5S board daily. + Assists Packer to meet the requirement of a minimum of 1 load on the floor fully packed and ready to be loaded. + Assists or replace Picker or Loader or as needed due to assignment demands or absenteeism. + Picks, packs, and stages rejects. This must be completed no later than the close of the next business day after issuance. + Picks, packs, ships, other orders or miscellaneous shipments other than Finish Goods. + Delivers shipping documents/labels to other departments and pick up supplies or items from other departments. + Empties scrap wood bin at least once per week or as needed. + Picks up or return pallets and scrap pallets. Completes and submits pallet transfer documents. + Consolidates rows and racks when no rejects are needed. Loader + Wraps or bands pallets as specified in SOPs and special instructions. + Applies pallet labels, slip sheets or covers as required. + Loads trailers using best configurations and customer specifications. + Blocks and braces loads while loading trailers. + Inspects, maintains, and operates wrappers. + Alternates "Trailer Loader" and Wrapper Loader" with each load. + Completes all required shipping document including SOPs. + Supports teammates as needed. **DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:** + Other duties as assigned with or without accommodation. + These are duties in additional to the assigned duties of the Picker, Packer, Rover, and Loader positions. + Identifies and evaluates the cause of areas of concern, problem areas or opportunities and offers practical solutions for continuous improvement in customer satisfaction, efficiency and safety. + Have a working knowledge of all tools and equipment utilized in the warehouse. + Utilizes software system(s) to identify order specifications, products, and inventory specifications. + Complies with department and company policies including but not limited to; "Cardinal Rules", PTO, start times, breaks, safety and cGMP practices. + Completes and passes all training modules and courses by their specified completion date. + Maintains designated zone in a continuously clean, orderly condition. + Completes daily assigned work as per the Daily Pack and Load Plan. + Alerts the Logistics Supervisor by speaking directly with him/her immediately if you believe you are unable to meet any of the duties as described. In the Supervisor absence, speaks directly with the Logistics Manager. **MINIMUM REQUIREMENTS** **:** _Education:_ High School Diploma, GED, or equivalent. _Experience:_ Minimum 3 years experience in a cGMP warehouse with particular knowledge of safety procedures, equipment operations, troubleshooting, and using proper work procedures. Possess a valid Driver's License. Computer literate with skills in Microsoft Office. _Preferred Skills/Qualifications:_ _Other Skills:_ _Competencies:_ Must have excellent communication skills. Working knowledge of the metric system and the ability to convert kilograms to pounds. Some Lean Manufacturing knowledge and experience is a plus. Ability to operate Warehouse shipping equipment, e.g., fork truck, trailer spotting tractor (Yard Dawg), use power equipment, hand tools, bar code scanners and basic computer. Written Communication, Problem Solving, Interpersonal Savvy, Organizing **RELATIONSHIP WITH OTHERS/ SCOPE:** + Directly reports to Shipping and Receiving Supervisor. + Although responsibilities are governed by policies and procedures, much of the work is performed without direct supervision; therefore, personal judgment must be exercised in pacing the work and adhering to the highest standard of quality in the absence of supervision. + Frequently maneuvers large, heavy drums filled with product (100 to 220 lbs.) manually while loading trucks or preparing orders. This handling includes rolling and pushing/pulling requiring 80 lbs. /force. Further exertion is required to strap drums on a pallet as well as rolling and stacking drums while loading trucks. Must be able to withstand extreme heat and cold when working loading trucks. + Must be able to visually identify an ever-increasing number of products and codes at a glance. A great deal of awareness is required to understand shipping instructions and to interpret the many guidelines for each functional procedure. Must be able to enter and transact inventory data and order information in the computerized system(s). + Must be able to safely and efficiently operate forklifts, shrink wrappers, spotting tractors, power tools, strapping tools, safety equipment, bar code scan guns, ladders, a number of hand tools and miscellaneous equipment. + Must handle and package finished goods with care to avoid product damage, which could result in customer rejection of product. + Not directly responsible for work of others; although the team concept requires coordinated efforts such as driving forklifts, loading, labeling, checking and double-checking of inventory items or picked/packed finished goods. + Must be able to communicate and work with all departments and personnel on site. **WORKING CONDITIONS:** + All work is performed in unheated and uncooled environments; this includes working site outside and in trailers in all types of weather. + The constant use of dangerous equipment and handling of hazardous materials presents an ever-present hazardous working environment. + Occasional heavy lifting (up to 68 pounds without assistance), bending, climbing, use of hand and power tools. + Frequent pushing/pulling of maneuvering heavy drums using 80 lbs. of force, walking, climbing, reaching, handling/grasping. + Must be able to wear the required personal protective equipment (PPE), as deemed necessary for each job task as assigned by EH&S. **DISCLAIMER** **:** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. **EEO Statement:** We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
    $30k-37k yearly est. 60d+ ago
  • Sr. EHS Specialist

    Endo International 4.7company rating

    Raleigh, NC job

    **Why Us?** At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. ** Summary** SUMMARY OF POSITION: An integral member of the site EHS Department, whose primary responsibilities are to ensure a safe and healthy working environment through training, awareness, and compliance with various environmental, health, safety and security (EHSS) corporate policies, federal regulations, and other generally recognized standards and guidelines. You must possess the proper skills in order to identify hazardous workplace conditions, remove hazards and/or protect employees through development and implementation of Job Safety Analyses (JSA's) and risk assessments, in an effort to continually improve the organization's safety culture. The Sr. EHS Specialist will also assist the Environmental Engineer in the areas of air and water quality type activities as they relate to site activities and operating permits limits. You will be tasked with taking a lead role in revising and improving the site's EHS procedures and management systems. **Job Description** **ESSENTIAL FUNCTIONS** **:** + Ensures a safe and quality working environment through training, awareness, and compliance with safety SOP's, corporate standards and OSHA regulations + Assist with various EHSS inspections / audits including but not limited to state or federal agencies or required periodic 3rd party audits. + Leads efforts as a team member in analyzing and continually improving the site's Safety Culture. + Develops and mentors others in developing Job Safety analyses (JSA's) and risk assessments. + Monitors and takes effective steps to ensure that workplace conditions comply with applicable federal and state occupational safety and health standards. + Ensures that all required records are prepared and maintained. + Investigates and prepares required reports on injuries and incidents. + Conducts safe work procedures and other safety training courses. + Provides input on equipment installation, start-up operation, and trouble shooting. + Ensures accountability, transparency, and effective communication cross-functionally and within the safety team and the EHS Department while guaranteeing information is timely, clear and accurate. **DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:** + Other duties as assigned with or without accommodation. + Develop and apply a strong technical knowledge of Albemarle's Policies and Procedures covering Health, Safety and Environment. Other functions may include Regulatory Reporting, Employee training, and assistance contractor management. + Key contributor for policy updates, creation, and implementation + Document and communicate EHS Expectations, Outcomes and Metrics. + Leading planning and execution of Risk Assessments and EHS Audits + Required to participate in department on-call schedule. + Assists with project reviews for compliance needs. + Assists with Emergency Response training and response activities. + Be an active member in the site's emergency response Incident Command Team + Participate in continuous improvement activities and champion change when faced with adversity while incorporating team input. + Supplies the highest level of internal and external customer service while having the ability to diplomatically challenge established procedures and systems. **MINIMUM REQUIREMENTS** **:** _Education:_ B.S. degree in Occupational, Safety, and Health Engineering or related safety/technical field. Advanced degree and/or professional certification (CSP, CHMM, CIH, PE) is a plus. _Experience:_ Minimum 5 - 10 years of experience as a EHS professional required. Previous EHS experience in a pharmaceutical, chemical, or manufacturing environment working with hazardous materials preferred. Experience in industrial hygiene monitoring activities, data interpretation and report writing. Experience with internal and external audits and inspections for regulatory compliance. Experience in developing and delivering personnel training _Skills/Qualifications:_ _Other Skills:_ _Competencies:_ Must be able to walk, climb, and wear personal protective equipment (PPE) to include full body suit and respiratory equipment. Working knowledge of Title 29, Code of Federal Regulations Part 1910 and Part 1926; Working knowledge of various North Carolina Division of Environmental Quality regulations as they relate to Air Quality, Water Resources, and Waste Management. Working knowledge of various NFPA, ASME, and similar industry standards/guidelines. Skill in evaluating, planning (including strategic planning), organizing and reviewing regulations to determine compliance with various federal regulatory requirements and corporate EHS policies. Ability to prepare and communicate technical data for use by a variety of different audiences, such as the Site Leadership, supervisors, senior engineers/scientists, technical expert, and operators. Ability to use safety management and engineering practices for the continuous improvement of Plants TRR and workers compensation rates. Excellent communication, interpersonal and technical writing skills. Strong interpersonal skills. Ability to handle multiple priorities. Detail-oriented with the ability to work under tight deadlines. Decision making, problem solving and analytical skills. Conflict management skills. Strong proficiency in Microsoft Office applications required.. Knowledge of FDA's Good Management Practices (cGMP) Ability to effectively communicate with all levels of the organization, from operations to senior management, both oral and written format. Action Oriented, Drive for Results, Problem Solving, Timely Decision Making, Written Communications, Process Management, Time Management, Organizing **RELATIONSHIP WITH OTHERS/ SCOPE:** + This position reports to the EHSS Manager. + The Sr. EHS Specialist supports the EHSS goals and functions of the pharmaceutical manufacturing facility. + This position interacts with all levels of the facility from production operators to senior site leadership. + Ability to effectively interact with manufacturing, maintenance, and medical departments. **WORKING CONDITIONS:** + This position works both in the office and plant setting, both indoors and outdoors. + Outdoor conditions will include the temperature and weather extremes. + Work outside of normal business hours may be required including working early, staying after normal working hours, weekend work, or holiday work. + This position will rotate on-call duties, which include weekend/holiday coverage of plant operations. + Physical demands of this job include climbing stairs and extensive periods of walking and standing. + Exposure to fugitive emissions of chemicals typical for chemical operations. + Must be able don required personal protective equipment (PPE), such as hard hats, safety glasses, safety shoes, flame resistant clothing, respiratory protection, chemical protective suit, etc., as deemed necessary by EHS. **DISCLAIMER** **:** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. **EEO Statement:** We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
    $46k-64k yearly est. 5d ago

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