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West-Ward Pharmaceuticals jobs - 26 jobs

  • Specialist, Talent Acquisition

    Hikma Pharmaceuticals 4.9company rating

    Hikma Pharmaceuticals job in Columbus, OH

    Job Type: Full-time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' mission is to bring Better Health. Within Reach. Every Day. for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Specialist, Talent Acquisition to join our team. In this role, you will be responsible for managing the full lifecycle recruiting process from open requisition to offer stage, including, but not limited to, job specification and development, prescreening and qualifying top candidates, interviewing and negotiating offers. Considerable skill in interviewing techniques, advanced knowledge of proactive recruiting techniques and sources, a well-rounded understanding of the Company's organizational structure as well as an extensive knowledge of personnel policy/procedure and federal/state laws regarding employment practices. Develops and executes staffing strategies for a variety of levels staffing to executive placement; develops, streamlines and enhances staffing systems, tracking, reporting and analysis; leads sourcing and recruiting initiatives and processes to leverage networking and employee referrals; manages college relations and oversees various sourcing and internship programs; manages relocation, immigration and other responsibilities related to staffing administration; ensures compliance with all state and federal discrimination and employment regulations. Key Responsibilties: * Regular and predictable onsite attendance and punctuality. * Manage full lifecycle recruiting process from open requisition to offer stage, including, but not limited to, job specification and development, pre-screening and qualifying top candidates, interviewing and negotiating offers. * Responsible for entry-level to mid-level roles. Other roles as assigned. * Understand functional hiring needs and translate those needs into effective passive and active sourcing strategies. * Review resumes, portfolios and credentials for appropriate skills, experience and knowledge in relation to position requirements. * Successfully source and screen candidates and present them to appropriate hiring teams. * Understand candidate requirements, providing compensation guidance to the business to successfully negotiate and close candidates. * Leverage skills to develop and deliver a strategic recruiting strategy with internal managers in order to recruit top talent. * Communicate proactively and regularly with Hiring Managers and Candidates to ensure a seamless recruiting experience. * Be the liaison between the candidate(s) and management throughout the hiring process. * Seek out candidates that add value to the organization and maintain regular contact with possible future candidates. * Build positive relationships with candidates throughout the recruitment process to ensure a high-quality candidate experience. * Develop and maintain a network of professional contacts to help identify, source and engage talent. * Collect, interpret and review interview feedback with hiring managers. * Ensure that the recruiting process complies with employment laws, regulations and internal processes. * Performs other duties as may be assigned. * Stays abreast on cutting-edge advertising opportunities, making recommendations to participate when deemed appropriate, in order to capitalize on recruiting opportunities. * Develops promotional material to aid in staffing. * Proactive research of industry competitors and overall familiarity with local and regional talent pools. * Leverage online recruiting resources to identify top talent. * Be creative in recruiting, using various methods including, but not limited to; Internet, print, job fairs, universities, vocation schools, etc. * Participate in the college recruitment process (information sessions, on campus interviews and career fairs). * Develops and maintains professional relationships with colleges, universities, community organizations and professional associations as a source to generate qualified applicants. * Researches, analyzes, prepares and presents internal staffing trends, retention strategies, etc. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: * Bachelor's Degree; prefer degree in HR, Organizational Development, Marketing or Business Administration * Minimum of 2-5 years of recruiting/staffing experience * An understanding of human resources principles and practices * Excellent communication skills, attention to detail and ability to multi-task * Ability to work independently and proactively anticipate the needs of the business * Ability to work in a fast-paced, high volume work environment * Ability to interact well with all organizational levels * Must be able to maintain confidentiality * Outstanding time management skills * Proficiency in office computer software/systems (MS Office, Word, Excel, requisition/candidate tracking systems) * Must have strong written and oral communication skills * Must have an engaging personality and be able to respond quickly and positively to change What We Offer*: * Annual performance bonus, commission, and share potential * Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute * A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries * 3 personal days (prorated based on hire date) * 11 company paid holidays * Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits * Employee discount program * Wellbeing rewards program * Safety and Quality is a top organizational priority * Career advancement and growth opportunities * Tuition reimbursement * Paid maternity and parental leave * Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. Location: Columbus, OH, US, 43228 Nearest Major Market: Columbus
    $41k-59k yearly est. Auto-Apply 42d ago
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  • Director, Quality Unit - 503B

    Hikma Pharmaceuticals USA Inc. 4.9company rating

    Hikma Pharmaceuticals USA Inc. job in Dayton, OH

    Job Type: Full-time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We continue to be committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Director, Quality Unity - 503b. In this role, you will be responsible for handling several key responsibilities to ensure the highest standards of quality and compliance. This role requires hands-on leadership and a deep understanding of the compounding process as this role also requires a comprehensive knowledge of the specific regulations governing 503B outsourcing facilities, which are distinct from those for traditional pharmaceutical manufacturing. The FDA's guidelines for 503B facilities are more stringent in certain areas, particularly regarding sterility and batch testing. Key Responsibilities: Quality Assurance and Control: Oversee the development and implementation of quality assurance programs targeted at 503B processes. Manage the quality of compounded medications, which can be more complex due to the customization and variability in formulations. This includes ensuring the sterility and stability of our compounded products. Ensure compliance with FDA regulations and cGMP Conduct regular audits and inspections to maintain quality standards. Take active leadership in FDA and other Health Authorities audits Team Leadership: Lead and mentor the quality unit team. Provide training and development opportunities for staff. Foster a culture of continuous improvement and quality excellence. Regulatory Compliance: Maintain up-to-date knowledge of regulatory requirements. Ensure all products meet regulatory standards before release. Manage documentation and reporting for regulatory submissions. Operational Oversight: Direct oversight of compounding processes, including aseptic techniques and equipment validation. Oversee batch record creation, materials testing, and quality systems. Lead investigations into non-conformances and implement corrective actions. Ensure proper aseptic techniques and equipment validations are followed. Collaboration: Work closely with compounding pharmacists, other departments such as manufacturing, R&D, Regulatory Affairs and supply chain. Participate in cross-functional teams to address quality issues and improve processes. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: Education: Bachelor's or Master's degree in Pharmacy, Chemistry, or a related field. Experience: Extensive experience in pharmaceutical quality assurance/control, preferably in a 503B compounding environment. Skills: Strong leadership, communication, and problem-solving skills. Proficiency in quality management systems and regulatory compliance. Compensation: Base Salary: $121,350 to $220,850 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
    $121.4k-220.9k yearly 60d+ ago
  • Project Lead, Maintenance

    Hikma Pharmaceuticals 4.9company rating

    Hikma Pharmaceuticals job in Columbus, OH

    Job Type: Full-Time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' mission is to bring Better Health. Within Reach. Every Day. for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 750 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Project Lead, Maintenance to join our team. In this role, you will be responsible to Coordinate and communicate effectively with cross-functional teams, including project managers, production engineers, and technicians. Lead Continuous Improvement (CI) through packaging process/material optimization (Life-Cycle Management) and the implementation of innovative new technologies/materials. Provide service and technical leadership, coordinate work activities, and establish priorities within a team to ensure customer service needs are met for the manufacturing, site and/or packaging equipment. Review work of other PRT/MRT's and provide feedback to performance. Ensure reliable manufacturing, packaging, and/or site facility equipment by troubleshooting, adjusting, repairing, rebuilding, fabricating, predicting failures, and replacing components and coordinating vendor support to ensure equipment performance is reliable and meets expectations with root cause analysis of failures with support from Engineer and/or Optimizer. Perform preventive, corrective, or emergency work orders and respond to service calls while the plant is in operation, which may include off-shift periods and weekends. Actively participate in, and sometimes leads, equipment FATs to support production engineering efforts and support installation and training of new equipment to the facility. Key Responsibilities * Performs preventive, corrective, or emergency work orders and respond to service calls while the plant is in operation. * Guide other MRT's in and lead team initiatives such as maintenance best practice initiatives, root cause analysis and performance center (PC) meetings to identify and resolve manufacturing, packaging and/or site facility issues on a real-time basis. * Trains and mentors other MRT's in technical skills and abilities. * Provides input/suggestions to procedures, policies, work instructions and task sheets relating to maintenance and equipment certification. * Ensures team has required tools, supplies, and work areas necessary for completing required maintenance tasks in area of responsibility in accordance with 5S+1 principles to ensure a safe and efficient work area and to eliminate clutter and foreign particles that could potentially damage equipment or product. * Resolves issues and improves operations by making necessary changes to support continuous improvement by completing work on time and driving to improve work processes and procedures relative to manufacturing, packaging and/or site facility equipment. * Initiates, leads, and works with Engineers, Project Manager and Vendors on projects and improvement initiatives to ensure equipment meets site standards, this may include support for Factory Acceptance Testing (FAT) or Site Acceptance Testing (SAT) and related travel. * Initiates and executes change controls and test protocols in support of the qualification of new and existing equipment. * Reviews project designs and make recommendations for equipment accessibility and reliability. Leads the project team to communicate results and facilitates proper hand-off from project team to long-term process and/or equipment owners. * Influences the project layout, design, schedule, part ordering, and installation. * Serves as key contact for equipment projects (< $500K) within area of responsibility and represent operations interest in capital projects > $500K. * Monitors the manufacturing, packaging, and/or site facility areas and related equipment to identify problems or opportunities and identifies root cause and remediation of failures either independently or with support of others for repairs or process improvements to efficiency and/or reliability of manufacturing, packaging, and/or site facility equipment. * Communicates regularly with management and customers regarding the state of facility and utility equipment, status of work, known problems, and improvement initiatives. Effectively interacts across functions, departments, and teams to achieve site goals. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: * High school diploma or equivalent. * Certification / degree from an accredited organization / society / university or subject matter expert on critical equipment. * Minimum 8 years' experience with extensive maintenance of industrial equipment; including, but not limited to manufacturing, packaging and/or site facility equipment. What We Offer*: * Annual performance bonus, commission, and share potential * Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute * A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries * 3 personal days (prorated based on hire date) * 11 company paid holidays * Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits * Employee discount program * Wellbeing rewards program * Safety and Quality is a top organizational priority * Career advancement and growth opportunities * Tuition reimbursement * Paid maternity and parental leave * Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. #LI-KJ1 Location: Columbus, OH, US, 43228 Columbus, OH, US, 43228 Columbus, OH, US, 43228 Nearest Major Market: Columbus
    $71k-103k yearly est. Auto-Apply 60d+ ago
  • Supervisor, Flow Operations

    Hikma Pharmaceuticals 4.9company rating

    Hikma Pharmaceuticals job in Columbus, OH

    Job Title: Supervisor, Flow Operations Job Type: Full-Time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' mission is to bring Better Health. Within Reach. Every Day. for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 750 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Supervisor, Flow Operations to join our team. In this role, you will be responsible for providing functional leadership on day-to-day operations spending 70% of your time coaching and developing team(s). Key Responsibilities Note: Entry-level supervisors (level 13) are developing and are new to the role. They will perform the below job tasks with the heightened oversight of their manager or more-tenured supervisor-peers to navigate most routine issues (personnel, training, quality, shift resource performance, etc.). Experienced supervisors (level 14) perform the below job tasks with greater proficiency and autonomy and require little-to-no oversight to manage these same routine issues on their shift. * Regular and predictable onsite attendance and punctuality. * Coach and counsel team. * Build accountability and share commitments with the team using Action Items: what, when, who. * Ensure expectations, desired outcomes, and consequences are clearly stated and understood. * Document Performance * Foster career development and growth * Develop and utilize effective teaching, coaching, counseling and disciplinary skills; utilize the five coaching techniques (Bridge of Confidence, Socratic Method, 4:1, Action Items, 10-80-10). * Provide strong, effective leadership to team. * Create an environment that encourages initiative and risk-taking. * Set stretch goals. * Communicate daily within and across shifts. * Work with team to identify obstacles and resolve problems. * Identify resources and solutions to remove obstacles. * Assess processes and practices to identify areas of improvement. * Identify and utilize resources to assist with process improvements. * Develop and maintain a thorough knowledge and understanding of policies, procedures, equipment, job tasks and other items relating to the team. * Utilize knowledge and experience to make informed decisions within guidelines. * Review policies, procedures, etc., to identify gaps and needs. * Ensure employees are trained and knowledgeable on changes, revisions and new policies, procedures, etc. * Ensure team activities are conducted in compliance with safety rules and regulatory issues. * Work with management to establish KPIs. * Monitor performance relating to KPIs. * Identify issues which interfere with the team's ability to accomplish KPIs and act upon them. * Ensure compliance with regulatory, safety, cost, KPIs. * Communicate KPIs to team. Qualifications * Minimum: * Associate's Degree; other related experience may be considered in lieu of a degree * Expectation of successful completion of required management onboarding and development programs. * Preferred: * BS/BA degree preferred in Science, Engineering, Manufacturing, Industrial Technology, Business, or a related degree (based upon departmental requirements). Experienced Supervisors (level 14) will have at least 1 year of successfully demonstrated supervisory/management experience at Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. Location: Columbus, OH, US, 43228 Nearest Major Market: Columbus
    $34k-54k yearly est. Auto-Apply 40d ago
  • Summer Internship - Regulatory Affairs, Labeling

    Hikma Pharmaceuticals 4.9company rating

    Hikma Pharmaceuticals job in Columbus, OH

    Job Title: Intern - Regulatory Affairs, Labeling Job Type: Intern Compensation: $19.00/hour Internship will commence in May and end no later than August. About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated College Summer Intern for our Regulatory Affairs team at our Columbus, Ohio site. As an Intern, you will earn practical experience as a fully integrated member of our team and participate in meaningful projects that will add value to our organization. In this role, you will provide support to the various Regulatory Affairs groups. Responsibilities: * Evaluates RLD updates and applies necessary revisions to company labeling. * Works closely with regulatory team to provide regular updates on tasks. * Assist in updating the comprehensive product list. * Inputs meta data for products into the RIM system. * Drafts annual reports for inactive products. * Prepare redlines for artwork updates. * Assist the Regulatory Affairs labeling team with daily tasks. * Perform an audit of the current drug listings on DailyMed to ensure compliance. * Other duties as assigned. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: * This internship will work 1st Shift hours. * Regular and predictable onsite attendance and punctuality. * Must be an Undergraduate, Graduate, or Professional Student in good academic standing. * Must have completed 12 credit hours within a related major and/or other related coursework. * Desired competencies include strong communication skills, taking initiative, detail oriented, and good teammate. * Strong analytical and problem-solving skills (Business & Technical Knowledge) * Ability to work independently and manage multiple tasks simultaneously. * Highly motivated and inquisitive with a strong desire to learn. * Organization skills to manage multiple tasks with strong attention to details. * Planning and Organizational skills. * Proficient usage of Microsoft Office applications. * Strong mathematical, analytical, and problem-solving abilities. * A positive, self-starting, can-do attitude, and a willingness to jump in to support the team. * Excellent verbal and written communication skills, ability to communicate in a clear and persuasive manner, and attention to detail. * Must be legally authorized to work in the United States without restriction, no sponsorship offered at this time. * Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background. * Must be willing to take a drug test. * Must be 18 years of age or older. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. #LI-KJ1 Location: Columbus, OH, US, 43228 Nearest Major Market: Columbus
    $19 hourly Auto-Apply 4d ago
  • Regional Account Manager

    Tris Pharma 4.2company rating

    Ohio job

    Tris Pharma, Inc. (******************* is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology. Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success. We have an opening in our Cinicinnati/Columbus territory for an experienced Regional Account Manager. This is a field-based role requiring extensive travel providing sales coverage, account management and cross-functional collaboration to meet evolving organizational needs. Qualified candidates must live within territory. Regional Account Managers integrate national sales and account management responsibilities, focusing on both healthcare provider (HCP) relationships and strategic corporate account management to drive optimal patient access and product success. Serving as a direct link between the company, HCPs and corporate accounts, incumbent ensures alignment with corporate objectives and demonstrates the highest ethical and professional standards. She/he collaborates cross-functionally with Commercial, Medical and other internal departments and external resources on sales related issues. The Regional Account Manager demonstrates the highest ethical and professional standards with all business contacts to establish and maintain excellent reputation within the medical and pharmaceutical community. ESSENTIAL FUNCTIONS Adheres to all Standard Operating Procedures (SOPs), policies, processes and compliance guidelines and ensures knowledge of legal and regulatory requirements to appropriately respond to sales inquires, disseminate scientific information and report Adverse Events (AEs) and Product Quality Complaints (PQCs) Supports Healthcare Sales and HCP engagement by establishing, developing and maintaining successful partnerships with targeted HCPs and staff across assigned territory; Educates medical professionals on clinical and economic benefits of company products; Provides HCPs and medical staff with training on product use, efficacy timelines, side effects and risks, ensuring compliance with all regulatory requirements Creates consultative, solution-oriented business partnerships to meet identified needs and foster product awareness; Identifies and capitalizes on growth opportunities, addressing market changes proactively to meet short- and long-term goals • Develops and maintains relationships with key Corporate Account stakeholders (i.e., Integrated Delivery Networks (IDNs), Teaching Institutions, Employer Groups, Patient Advocacy Groups, etc.); Leverages relationships with IDNs, teaching institutions etc. to influence care protocols and integrate clinical pathways to improve patient outcomes Serves as corporate market access expert, collaborating cross-functionally to optimize positioning and formulary coverage; Executes strategic corporate account plans to ensure product success pre- and post-launch; Provides marketplace intelligence on customer trends, competitive updates and new opportunities Collaboratives closely with Regional Sales Managers (RSMs), Medical Science Liaisons (MSLs), Account Directors and Field Sales to align on sales and account strategies for optimal execution; Proactively addresses issues to ensure alignment across internal teams and external stakeholders; Serves as a key contributor to corporate initiatives and market penetration efforts Requirements KNOWLEDGE/SKILLS/ABILITIES Bachelors degree and minimum 4 years sales experience REQUIRED Proven success in exceeding sales targets and managing territories independently REQUIRED Key account management experience in a pharmaceutical, biotechnology or related industry PREFERRED Expertise in engaging Integrated Delivery Network (IDN) and Long Term Care (LTC) stakeholders, including C-Suite executives PREFERRED Experience with product launches and navigating reimbursement and formulary channels REQUIRED Proficiency in using Health Economics Outcomes Research (HEOR)/pharmacoeconomic data to influence formulary decisions REQUIRED Demonstrated ability to analyze complex sales and technical data and to develop strategic and actionable business plans REQUIRED Excellent presentation skills and experience REQUIRED Excellent scientific and business acumen REQUIRED Valid US drivers license and clean driving record REQUIRED Anticipated salary range: $125 to $145K/yr. Base salary offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity. Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups. Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-remote
    $125k-145k yearly 3d ago
  • Specialist, Lab Metrology

    Hikma Pharmaceuticals 4.9company rating

    Hikma Pharmaceuticals job in Columbus, OH

    Job Title: Specialist, Lab Metrology Job Type: Full time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' mission is to bring Better Health. Within Reach. Every Day. for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 750 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Specialist, Lab Metrology to join our team. In this role, you will be responsible for performing aspects of group activities, such as compliance, maintenance, and repair of laboratory instrumentation and all related documentation. Offers mentoring such as, training sessions, and troubleshooting techniques. Key Responsibilities: Writes and reviews departmental work instructions (WI's). Identifies work instructions which require updates based on new processes, instrumentation, and regulatory requirements. * Coordinates with management for content and to meet established timelines. * Communicates with Scientists and gain buy-in for procedure updates. * Build consensus with QLABS management and analyst for procedure harmonization. Performs instrument calibrations and monitors the calibration program * Maintains, performs, reviews, and schedules calibrations. * Communicates directly with service engineers and Quality Laboratory management for impacted instrumentation. * Identify root causes for instrumentation failures through impact assessment process with laboratory management. * Communicate with Flow lanes to document and complete CAPA's. * Receives quotes from vendors. Reviews Installation Qualification, Operational Qualification, Performance Qualification (IQ OQ PQ). Conducts instrument repairs to ensure working and efficient laboratories through trending and data analysis. Identifies instrumentation which are no longer reliable or able to be maintained. * Shows initiative and proactively works with Flow lanes to determine which instruments to retire. * Performs and/or coordinates repairs either individually, with a team, maintenance department, or with outside engineers. * Maintains, reviews, and schedules in database. * Communicates directly with service engineers. * Able to trouble-shoot in a timely and effective fashion to enable labs to meet deadlines. Mentors analysts on new or improved instrumentation and techniques To ensure growth and development of analysts as well as compliance. * Trains required individuals and provides input on training modules for new/revised equipment. * Prepares materials such as one point lessons. Identifies opportunities for improvement in laboratory instrumentation to ensure working efficient laboratory. * Performs needs assessments with QLABS and Analytical Development for new technologies. * Based on data available provides recommendations to management for new equipment purchases and drafts justification for purchase (APR). * Drives cost-savings in the lab through thorough review of all instrument and service quotes. * Must be familiar will most types of analytical instrumentation (HPLC, UV, GC) - theory, operation, and trouble shooting. * Extremely strong problem-solving skills and able to make general repairs to all types of laboratory equipment. * Strong computer skills - able to learn new software on the fly, troubleshoot basic computer problems. Set up and interface computer systems with lab instrumentation. * Strong communication skills - written and oral - with the ability to teach and convey technical knowledge and develop training materials for others to use. * Knowledge of GMP regulations, analytical instrument qualification, calibration, and DP requirements. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: * Bachelor's Degree in Scientific/Technical field required with a minimum of 3 years' experience in a QC pharmaceutical laboratory or related industry (food, chemical, or environmental). Experience as laboratory instrumentation field service technician may be considered. What We Offer*: * Annual performance bonus, commission, and share potential * Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute * A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries * 3 personal days (prorated based on hire date) * 11 company paid holidays * Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits * Employee discount program * Wellbeing rewards program * Safety and Quality is a top organizational priority * Career advancement and growth opportunities * Tuition reimbursement * Paid maternity and parental leave * Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. Location: Columbus, OH, US, 43228 Nearest Major Market: Columbus
    $42k-59k yearly est. Auto-Apply 8d ago
  • Sr. Process Engineer - Technical Services

    Hikma Pharmaceuticals 4.9company rating

    Hikma Pharmaceuticals job in Columbus, OH

    Job Type: Full time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We continue to be committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Sr. Process Engineer - Technical Services. In this role, you will be responsible for Leading the Registration/ Process Validation (Process Design, Process performance qualification, & Continuous Process Verification)/ Process transfer of in-house products (on-site development/ transferred or procured filings/ re-launch etc.) and champion cross coordination with multiple groups and alignment with Hikma's quality/ compliance requirements. Leading the transfer of 3rd party/ CMO products (externally contracted for development/ manufacturing/ testing, Buy-ins, Site Transfers (in/ out), life-cycle) from R&D to Commercial Operations as a Process Champion from Hikma. Developing and executing production strategies (e.g batch record documentation, GMP systems set-up etc.) for evaluation, scale-up, process validation, site transfer (in/out), and lifecycle products of multiple dosage forms (solids, non-solids, semi-solids, nasals, inhalation, etc.). Coordinating agency (e.g. FDA) submission documentation requirements, quality investigations, process change management, and project communications during development/ transfer/ launch/ life-cycle projects. Mentoring junior process engineers and share best practices within Technical Services to continuously grow talent and enhance productivity. Key Responsibilities: 1. Consult as Process and Formulation Champion on cGMP/ FDA/ Hikma quality requirements and execute process registration (ANDA, NDA, PAS, etc.)/ scale-up/ validation and commercial production for 3rd Party/ CMO & in-house products during project selection, process development, filing, transfer, evaluation, launch and life-cycle phase. * Lead as Hikma's Technical Services representative for in-house process flow & equipment requirements for different products (solids, non-solids, nasals, inhalation, etc.) and spearhead 3rd Party/ CMO site visits, process and equipment requirements, and other technical considerations during project selection, and execution. * Drive gap and risk assessments including statistical data analysis for process scale-up, and process design/ improvement initiatives (e.g. PAT, DOE) during development/ registration/ transfer and lead mitigation and implementation activities. * Lead strategy development for filing and validation (e.g. lot sizes, number of lots, sampling plan etc.) and drive requirements (e.g. protocols, batch records, etc.) for registration scale-up, evaluation, transfer, and process validation batch production. * Create and/ or review documentation (e.g. Master Manufacturing Formula/ batch records, protocols/ reports, technical justifications for matrix approach etc.), and master data for production of batches for registration/ filing/ scale-up, evaluation, and process validation * Travel to 3rd party locations as lead representative of Process Transfer - Technical Services during registration/ evaluation/ scale-up/ process transfer/ validation/ commercial lot manufacturing to provide subject matter expertise and technical support on process and quality requirements of Hikma to mitigate risks during commercial production. 2. Lead process development, registration, and FDA filing tasks with R&D and project teams from 3rdparty/ CMO and Hikma to establish robust control strategy for future commercial process. * Collaborate with stakeholders (e.g. Product Development, Production etc.) during development, pilot lot production, registration, etc. to optimize or develop product formulation, and process flow, and resolve complex issues relating to CPPs, CQAs, AQL, analytical methods/ testing, quality deviations and other process risks. * Collaborate with Analytical Development, Quality labs etc. to set-up testing requirements for in-process controls, release and stability; influence in establishing product specifications based on process and data trends. * Co-lead with Product Development to generate development/ registration QbD reports and ensure robust documentation of development history/data prior to process validation/ PPQ. * Collaborate with Drug Regulatory Affairs (DRA) at 3rd Party/ CMO and Hikma to author/ or review documentation required for product filing (ANDAs, NDAs, PAS, CRLs, and other FDA correspondences) to support timely approvals. * Leverage lessons from registration scale batches and coordinate with Production/ Engineering team to drive procurement or modification of key manufacturing equipment to support commercial production. 3. Lead the planning and execution of process transfers and scale-up/ evaluation, process validation/ PPQ and commercial production/ CPV of new and existing products (3rd Party/ CMO, Transfer (In/ Out) Buy-ins, Inter-site etc.) following Hikma requirements; drive resolutions to complex process problems and influence teams to adopt solutions to meet commercialization/ product launch timelines/ deliverables. * Lead as a process champion/ point of contact for process validation (process design, PPQ, & CPV) / commercial production at Hikma * Lead proactive planning and strategies for the scale-up/ transfer/ validation lot manufacturing including commercial lot size determination, no. of lots for validation, documentation etc. to support product launch goals * Lead functional and cross-functional investigations in collaboration with Quality function of 3rd Party and Hikma to determine root causes, assess product impact, determine path forward, and develop/ implement CAPAs. Influence organizational partners to support these initiatives. * Lead process improvement/ optimization, CAPA, and other process changes during commercial manufacturing/ CPV stage. Influence organizational partners to support execution of these initiatives. * Coordinate with Quality/ Change Management, Drug Regulatory Affairs (DRA) etc. to lead the implementation of critical process changes (e.g. API/ raw materials, process parameters, batch size optimization etc.). * Lead the development of response strategies and corrective actions to resolve process quality/ product stability deviations on commercially marketed products in coordination with Quality, DRA, etc. * Support Life-Cycle Operations to plan and perform continuous process verification (CPV) or re-validation. 4. Mentor and develop other members of the Technical Services department and promote knowledge transfer within Technical Services. Act as a subject matter expert on core technologies and/or process engineering/ validation topics. * Identify and proactively create opportunities to mentor Process Engineer(s) on equipment/ process technologies, validation strategies, quality investigations/ CAPA, conflict management etc. * Lead knowledge sharing of best practices, quality and safety incidents, new process technologies, etc. within Technical Services organization. * Drive documentation to standardize best practices, and author Work Instructions, SOPs, etc. to support process documentation requirements under Hikma's quality management system. * Support Technical Services management to resolve complex challenges related to process/ equipment, validation, quality investigations etc. * Other duties as assigned Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: * B.S. degree in Engineering, Chemistry, Pharmacy, or related scientific discipline plus a minimum of six (6) years of experience in pharmaceutical technology transfer, project management, quality assurance, product development, manufacturing, or applicable pharmaceutical experience, or nine (9) years of experience in another technical field in product formulation development, process development, technology transfer and validation, and/or process engineering. * Alternatively, a M.S. degree in Engineering, Chemistry, Pharmacy, or related scientific discipline plus a minimum of four (4) years of experience in pharmaceutical technology transfer, project management, quality assurance, product development, manufacturing, or applicable pharmaceutical experience, or seven (7) years of experience in another technical field in product formulation development, process development, technology transfer and validation, and/or process engineering. * Alternatively, a Ph.D. degree in Engineering, Chemistry, Pharmacy, or related scientific discipline plus a minimum of two (2) year experience in pharmaceutical technology transfer, project management, quality assurance, product development, manufacturing, or applicable pharmaceutical experience, or three (3) years of experience in another technical field in product formulation development, process development, technology transfer and validation, and/or process engineering. * Expert implementation knowledge of applicable laws and regulations regarding development and manufacturing of pharmaceuticals, including FDA, cGMP, DEA, OSHA and other applicable regulatory and company guidelines. * Expert knowledge of pharmaceutical formulation development, processing equipment, quality by design, and cGMP production with emphasis on scale-up/ optimization and validation. * Demonstrated ability to develop, scale-up, and/or validate pharmaceutical processes for unique and challenging dosage forms (e.g. tablets, capsules, combination products (nasals, dry powder inhalation etc.), creams/ ointments, soft gels, transdermal etc.); Demonstrate strong learning agility towards process technologies that are outside of previous experience. * Ability to travel (domestically and internationally) to external organizations/ companies for multiple days to support project deliverables. * Attention to detail to documentation to ensure quality and accuracy. * Conflict Management: Demonstrated ability to work with professionals/ teams with differing perspectives from external/ contract organizations from different regions (domestic and international) and achieve mutually acceptable solutions. * Experimental Methodology: Demonstrated ability to design complex experiments to support pharmaceutical development/process transfer/validation. * Complex Problem Solving: Expert knowledge of and ability to apply investigative techniques to uncover problem areas, determine root causes, and drive corrective actions at both the individual and cross-functional team level. * Situational leadership: Demonstrated ability to independently work with no or minimal supervision to make strategic decisions and execute tactical tasks of high complexity. * Teamwork: Demonstrated ability to be an influencing participant on teams of high complexity, and to lead/facilitate teams on tasks of high complexity. What We Offer*: * Annual performance bonus, commission, and share potential * Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute * A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries * 3 personal days (prorated based on hire date) * 11 company paid holidays * Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits * Employee discount program * Wellbeing rewards program * Safety and Quality is a top organizational priority * Career advancement and growth opportunities * Tuition reimbursement * Paid maternity and parental leave * Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. #LI-KJ1 Location: Columbus, OH, US, 43228 Nearest Major Market: Columbus
    $81k-104k yearly est. Auto-Apply 60d+ ago
  • Summer Internship - Process / Medical Device

    Hikma Pharmaceuticals 4.9company rating

    Hikma Pharmaceuticals job in Columbus, OH

    Job Title: Intern - Process / Medical Device Job Type: Intern Compensation: $19.00/hour Internship will commence in May and end no later than August. About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. Hikma Pharmaceuticals is currently seeking a talented College Intern to join the Technical Services group, you will have an opportunity to work on diverse pharmaceutical drug products and combination products (drug product & medical device) including nasal sprays, inhalation powders, tablets, capsules, solutions, suspensions etc. at various stages of their lifecycle ranging from early-development to scale-up/ commercial launch. Your internship tenure will not only allow you to contribute towards Hikma's quality objectives and culture of putting "Better health. Within reach. Every day", but it will also directly impact lives of patients who rely on our products. Responsibilities: * Support Process Engineers with commercial batch production, cGMP documentation reviews, process optimization efforts, etc. * Employ statistical methods (e.g. Cpk, ANOVA, Regression analysis etc.) and AI/ML models/ applications to analyze data and assist in driving quality/ regulatory decisions. * Conduct physical properties, & performance testing of powders, tablets, capsules, etc. to support process validation activities. Support lifecycle review & continuous improvement of combination products by analyzing data from production, customer complaints, etc. * Support Subject Matter Experts (SMEs) in performing risk analysis (e.g. FMEAs) following ISO 14971/13485 & CFR 820 principles. * Support Tech Service department SMEs and management in other related duties and continuous improvement projects as assigned. * Other activities as assigned. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: * Pursuant of undergraduate or graduate degrees/ programs in Engineering, Pharmacy, Chemistry, or related scientific disciplines. * Prefer candidates with some prior work experience (at least 3 months) or academic research experience in the healthcare industry sector. * Prefer for candidate to have knowledge of cGMP pharmaceutical production processes and combination products or medical devices. * Prefer for candidate to have AI/ ML model development/ training, data analytics & programing skills with applications like MS- Excel, -Azure, -Power Apps, Minitab, SAS, etc. * Require candidate to be a critical and analytical thinker with good situational leadership and communication skills. * Candidates must meet cGMP, FDA, DEA, OSHA, and other applicable regulatory and Hikma guidelines. * Regular and predictable onsite attendance and punctuality. * Must be legally authorized to work in the United States without restriction, no sponsorship offered at this time. * Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background. * Must be willing to take a drug test. * Must be 18 years of age or older. * Must be an Undergraduate, Graduate, or Professional Student in good academic standing. * Completion of a minimum of 12 credit hours within a related major and/or relevant coursework such as materials management, inventory control, operations, or systems analysis. * Ability to work independently and manage multiple tasks simultaneously in a hands-on operational environment. * Strong organizational skills with a high level of attention to detail. * Effective planning and time-management skills. * Strong verbal and written communication skills, with the ability to communicate clearly with cross-functional teams. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. #LI-KJ1 Location: Columbus, OH, US, 43228 Nearest Major Market: Columbus
    $19 hourly Auto-Apply 4d ago
  • Summer Internship - Data Analytics

    Hikma Pharmaceuticals USA Inc. 4.9company rating

    Hikma Pharmaceuticals USA Inc. job in Columbus, OH

    Job Title: Intern - Data Analytics Job Type: Intern Compensation: $19.00/hour About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We are seeking a motivated and detail-oriented Data Analytics Intern to join our Advanced Analytics team. This internship offers a unique opportunity for hands-on experience in analytics projects with real-world impact. This role is ideal for students passionate about data, analytics, and technology who want to apply their knowledge to impactful business problems. This person will work closely with experienced professionals, gain practical analytics experience with leaders who know how to translate data into business decisions. Internship will commence in May and end no later than August. Responsibilities: Assist in designing and executing data analytics projects aligned with business needs Consolidate and transform customer forecast files into a unified database, starting with Excel and progressing toward automated solutions Investigate SAP data structures and relationships to support SQL-based data modeling for the enterprise data lake Develop and test Power BI prototypes to simulate data lake models and visualize key metrics Support proof-of-concept AI initiatives as needed Document processes, data flows, and findings to ensure clarity and reproducibility Collaborate with team members to troubleshoot issues and refine solutions Communicate insights and progress effectively to business stakeholders Other activities as assigned Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: Completed one year of college course work toward a degree in Business Analytics, Data Science, Computer Science, including at least 12 credit hours of related coursework. Must be an Undergraduate, Graduate, or Professional Student in good academic standing. Proficiency with some of the following analytical disciplines Data Manipulation and Analysis (Excel, SQL, Python) Business Intelligence Tools (PowerBI, Tableau, Celonis) Predictive Modeling and Machine Learning Concepts Database Design, Database Structure and Data Modeling Desired competencies include strong communication skills, taking initiative, problem solving skills, being detail oriented, and good teamwork. Highly motivated and inquisitive with a strong desire to learn. Proficient usage of Microsoft Office applications. Regular and predictable onsite attendance and punctuality. Must be legally authorized to work in the United States without restriction, no sponsorship offered at this time. Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background. Must be willing to take a drug test. Must be 18 years of age or older. This internship provides an excellent platform for aspiring analyst to develop their skills while contributing to exciting projects within our organization. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. #LI-KJ1
    $19 hourly 3d ago
  • Electrical Infrastructure - Sr. Automation & Controls Engineer

    Hikma Pharmaceuticals 4.9company rating

    Hikma Pharmaceuticals job in Columbus, OH

    Job Type: Full-Time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Electrical Infrastructure - Sr. Automation & Controls Engineer to join our team. In this role, you will be responsible for the management and execution of all Engineering activities related to the building electrical systems, including generators, transformers, switchgear, motor control centers & switchboards, UPS and other down-stream equipment. Key duties involve troubleshooting problems, performing repairs and ensuring equipment reliability to provide essential utility services. Provide operational support, complex troubleshooting, and optimization for automation equipment, directing and coordinating activities to improve reliability, and applying advanced engineering principles to the design and implementation of new equipment. Key Responsibilities: * Regular and predictable onsite attendance and punctuality. * Direct more complex group projects - identify, propose and champion creative and constructive solutions articulating the business value created. Monitor and communicate progress on all projects within the assigned portfolio to successfully deliver project scope, timeline and budget objectives. Maintain a "state of control" over systems by assuring maintenance of as-built drawings, system documentation and EX rating management. * Troubleshoot control and instrumentation systems to resolve complex equipment issues. Provide engineering expertise and technical guidance to maintenance to perform repairs, design changes, or other corrections as a result of troubleshooting or performance evaluation. Estimates project budgets and resource requirements. * Mentor peers and site resources on automation and control systems facility utility systems. Provide training and technical supervision to instrumentation and electrical personnel as well as Flow technicians for automation control systems throughout the site. * Develop test plans, implementation plans, and project timelines for various projects. * Write functional requirements/specifications documents. * Support the design, specification, installation, startup and validation of building electrical distribution equipment from medium voltage services to equipment MCC. Partner with Engineering lead of process control systems, electrical systems and instrumentation for capital and upgrade projects. Ensure site specifications, standards and cGMP compliance to expectations are met and that good engineering practices are followed. Coordinate with other engineers, project managers, and suppliers to ensure a complete and timely design and implementation. * Identify continuous improvement activities related to building electrical infrastructure, automation control systems throughout the site and champion solutions aligned with site and department metrics, Business Objectives and Strategy. Identify areas of opportunity to improve equipment and component reliability. * Review electrical equipment thermography study, interpret data & determine if action needs to be taken based on findings from study. * Update single line drawings, panel schedules, & control diagrams. * Review time current curves, determine best circuit breakers/ fuses for implementing based on equipment being used to reduce arc-flash, ensure transformers are protected correctly and reduce false motor overload trips Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: * Bachelor's Degree in Engineering * In lieu of a bachelor's degree, an additional four years of experience is required in the areas of engineering below. * Experience with network and system administration of Microsoft based systems. * Demonstrated computer skills, including but not limited to, MS Excel, Word, PowerPoint, and Project. * Proven ability to simultaneously manage multiple projects and initiatives. * Demonstrated successful communication and negotiation skills to manage conflicting and/or multiple demands, including ability to present to various level within an organization. * Demonstrated ability to apply analytical skills to identify problems; recognizes symptoms, causes, and alternate solutions and makes timely sound decisions even under risk and uncertainty. * Willingness to travel to external domestic and international supplier sites (typically less than 10% of the time). * Provide engineering expertise and technical guidance when necessary, including off-shift on-call support rotation. * 6+ years of experience in power distribution systems (utility to MCC/PP), process control systems, variable frequency drives (VFD) and automated control systems, preferably in the chemical, food, or pharmaceutical industries. Preferred Qualifications: * Programming/troubleshooting Allen-Bradley Programmable Logic Controllers * Experience supporting Building Utility Systems * AutoCAD What We Offer*: * Annual performance bonus, commission, and share potential * Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute * A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries * 3 personal days (prorated based on hire date) * 11 company paid holidays * Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits * Employee discount program * Wellbeing rewards program * Safety and Quality is a top organizational priority * Career advancement and growth opportunities * Tuition reimbursement * Paid maternity and parental leave * Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. #LI-KJ1 Location: Columbus, OH, US, 43228 Nearest Major Market: Columbus
    $70k-92k yearly est. Auto-Apply 60d+ ago
  • Aseptic Compounding Technician

    Hikma Pharmaceuticals USA Inc. 4.9company rating

    Hikma Pharmaceuticals USA Inc. job in Dayton, OH

    Job Title: Aseptic Compounding Technician Job Type: Full-time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Aseptic Compounding Technician. In this role, you will be responsible for preparing compounded sterile preparations according to batch record instructions, using expert aseptic technique to ensure product quality and safety. This shall include setting up and operating all compounding equipment, filling of medical device containers, equipment cleaning, and documentation of all related activities. This role requires a high level of attention to detail, technical expertise and strict adherence to quality and safety standards. Key Responsibilities: Regular and predictable onsite attendance and punctuality Accurately and aseptically prepare compounded sterile preparations according to batch record instructions and per internal SOPs and cGMPs to ensure the quality and integrity of products Gowning: Perform gowning procedures in accordance with company protocols and maintain gown qualification Demonstrate appropriate cleanroom behavior and apply aseptic technique principles to avoid contamination risk, including proper hand hygiene, garbing, and manipulation of sterile materials Set up and operate all compounding equipment safely and accurately according to policy and procedure Complete and maintain applicable logbook and batch record paperwork abiding by Good Documentation Practices (GDPs) Accurately document compounding activities including batch records and quality control checks Execute aseptic qualification and equipment qualification protocols as required Maintain aseptic qualification and gown qualification Collect environmental monitoring samples and perform other quality checks as necessary Escalate any and all process issues to the area supervisor or designee Perform thorough cleaning and disinfection of the Clean Room areas per internal SOPs Maintain good hygiene prior to coming into work each day Perform other related duties as determined by management personnel Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: Two (2) years of cGMP pharmaceutical manufacturing experience required. High School Diploma or equivalent required. Good oral and written communication skills are essential Must be able to document process issues in a clean, concise manner in accordance with cGMPs and SOPs Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form Must be able to read and understand complex compounding/formulation and filling procedures Ability to examine problem areas and make recommendations for corrective action Must be able to comprehend and follow all applicable SOPs Heavy continuous exertion Will be required to lift 5 - 40 pounds Must be able to stand for long periods of time Must be able to wear required PPE Work involves exposure to drug substances which may require special handling and protective equipment Must work in a cleanroom environment wearing company-issued scrubs, as well as a hood, coverall, boots, gloves, and goggles The noise level is moderate to loud in the cleanroom areas The use of sanitizing agents to clean the cleanroom areas may be moderately Ability to pass gown qualification testing and maintaining gowning proficiency is required within the assigned timeframe Preferred Qualifications: College degree (BA/BS) in Biological Sciences, Microbiology, or other related science field; PTCB CPhT certification or equivalent, PTCB CSPT certification or equivalent preferred. Cleanroom experience with training on aseptic technique; IV bag and/or syringe compounding experience is preferred. Certification as a Compounding Technician (CCT) or equivalent preferred Compensation: Hourly Rate: $25.00 per hour. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
    $25 hourly 60d+ ago
  • Sr. Manager, Operations

    Hikma Pharmaceuticals 4.9company rating

    Hikma Pharmaceuticals job in Bedford, OH

    Please insert Nearest Major Market: Cleveland
    $112k-155k yearly est. Auto-Apply 36d ago
  • Principal Engineer, Packaging - Tech Services

    Hikma Pharmaceuticals 4.9company rating

    Hikma Pharmaceuticals job in Columbus, OH

    Job Type: Full time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Principal Engineer, Packaging - Technical Services to join our team. In this role, you will be responsible for transferring products [(Generic commercialization, Site Transfers, Buy-ins, Third Party & key lifecycle (Alt. API)] from R&D or partners to Operations, including leading packaging development, registration, site transfers, start-up of commercial production, and transfer to lifecycle support. Minimize and remove obstacles during development, product transfer, validation, and commercialization through utilization of risk-mitigation strategies, best practice sharing, and influence with R&D, Operations, and external colleagues. Support department management as group representative in technical and business meetings. Act as a technical subject matter expert and mentor for the Technical Services group and the site. Key Responsibilities: Demonstrate influence, leadership, and influential teamwork skills with development partners/customers during the packaging development and registration of site transfers and new product NDAs and ANDAs, ensuring that all project timelines are met. * Provide packaging engineering expertise , i.e. critical review, assessment, influence and strategy, for responsible projects assigned within Organic Launch, Business Development, Contract Manufacturing Organization (CMO), Alternate API, and targeted dormant products. * Create all associated master data for assigned projects. * Create all associated structure technical data for assigned projects. * Create all specifications required for the container/closure systems for assigned projects. * Create all associated aggregation/serialization requirements for assigned projects. * Attend all required team meetings to support assigned projects and ensure to achieve key milestone datas. * Perform all necessary line trials, including all necessary documentation such as protocols/reports/PO's, to support proper evaluation of form, fit, function of proposed container closure systems. * Support all regulatory audits as required. * Generate all required regulatory submission documents for assigned projects and provide support in generating responses to regulatory authorities. * Support other Technical Service Packaging Engineers with peer review; as well as, provide appropriate mentoring. * Influence and Collaborate with Purchasing to source new packaging components, if needed. * Interact with outside vendors to design new packaging components. * Influence and Liaise with Change Management to support packaging component changes. * Meet cGMP, FDA, DEA, OSHA and other applicable regulatory and company guidelines. * Influence and Liaise with Flow Packaging group to ensure consultation of launch projects for efficient transfer of applicable projects for life cycle transfer. * Drive continuous improvement activities for launched products through initial commercial production phase, until transfer of launched products to lifecycle support with Operations. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: * B.S. degree in Chemistry, Engineering, Pharmacy, or related scientific discipline plus a minimum of 15 years of experience in pharmaceutical technology transfer, quality assurance, product development, packaging, or applicable pharmaceutical experience, or seven years of experience in product development, technology transfer, and/or packaging engineering in another technical field. * Alternatively, a M.S. degree in Chemistry, Engineering, Pharmacy, or related scientific discipline plus a minimum of 13 years of experience in pharmaceutical technology transfer, quality assurance, product development, packaging, or applicable pharmaceutical experience, or five years of experience in product development, technology transfer, and/or packaging engineering in another technical field. * Alternatively, a Ph.D. degree in Chemistry, Engineering, Pharmacy, or related scientific discipline plus a minimum of 10 years of experience in pharmaceutical technology transfer, quality assurance, product development, packaging or applicable pharmaceutical experience, or two years of experience in product development, technology transfer, and/or packaging engineering in another technical field. (Internship or co-op programs may qualify for work experience for those with Ph.D. degrees.) * Demonstrated ability to perform at expectations for the following Hikma competencies: Collaboration & Teamwork, Communication & Influence, Customer Focus, Planning & Organization, Taking Initiative & Drive For Results. * Expert knowledge and understanding of applicable laws and regulations regarding development and packaging of pharmaceuticals, including cGMP, DEA, and FDA guidances. * Demonstrated technical knowledge of pharmaceutical packaging environment and equipment with emphasis on scale-up/ optimization and validation for various dosage forms (e.g. modified/extended release, nasal suspensions, soft gels, bead/pellet coated products, film coated products, and/or novel delivery systems). * Experimental Methodology: Subject Matter Expertise in experimental methodology and ability to design complex experiments to support pharmaceutical packaging development. Proficiency in the use of statistical software for experimental design and analysis is preferred but not required. * Critical Thinking/Complex Problem solving: Ability to apply the PDCA principles (plan, do, check, act) and develop solutions for a variety of problems. * Computer Skills: Expert computer skills with the ability to enter data into and retrieve information from various software programs such as Microsoft Office (Work, Excel, PowerPoint, and Outlook) and SAP. * Mentoring / Coaching: Strong ability to coach and/or mentor both in and out of reporting structure (e.g. mentoring junior Process Engineers, providing guidance to production Coaches and Technicians regarding optimization opportunities). Preferred Qualifications: * 10+ years commercial molding experience * Experience with systems such as SAP, TrackWise, Veeva or a Manufacturing Execution System (MES). What We Offer*: * Annual performance bonus, commission, and share potential * Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute * A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries * 3 personal days (prorated based on hire date) * 11 company paid holidays * Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits * Employee discount program * Wellbeing rewards program * Safety and Quality is a top organizational priority * Career advancement and growth opportunities * Tuition reimbursement * Paid maternity and parental leave * Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. #LI-KJ1 Location: Columbus, OH, US, 43228 Nearest Major Market: Columbus
    $79k-109k yearly est. Auto-Apply 60d+ ago
  • Supervisor, Flow Operations 3rd Shift-Sun-Thur 10:00pm-8:00am

    Hikma Pharmaceuticals USA Inc. 4.9company rating

    Hikma Pharmaceuticals USA Inc. job in Columbus, OH

    Job Title: Supervisor, Flow Operations Job Type: Full-Time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' mission is to bring Better Health. Within Reach. Every Day. for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 750 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Supervisor, Flow Operations to join our team. In this role, you will be responsible for providing functional leadership on day-to-day operations spending 70% of your time coaching and developing team(s). Key Responsibilities Provides strong, effective leadership to team with regular and predictable onsite attendance and punctuality. Builds accountability and shares commitments with the team using Action Items: what, when, who. Ensures performance expectations, desired outcomes, and consequences are clearly stated, understood and documented. Fosters career development and growth through regularly conducted individual meetings Develops and utilizes effective teaching, coaching, counselling, and disciplinary skills that creates an environment conducive to initiative and risk-taking in the accomplishment of goals. Communicates daily within and across shifts and work with teams to identify obstacles and resolve problems. Assesses policies, procedures, processes, and practices to identify areas of improvement. Develops and maintains a thorough knowledge and understanding of policies, procedures, equipment, job tasks and other items relating to the team to make informed decisions. Ensures employees are trained and knowledgeable on changes, revisions and new policies, procedures, etc. Ensures team activities are conducted in compliance with safety rules and regulatory issues. Works with management to establish, monitor, and communicate KPIs. Qualifications Minimum: Associate's Degree; other related experience may be considered in lieu of a degree Expectation of successful completion of Lean Six Sigma White Belt Program Preferred: BS/BA degree preferred in Science, Engineering, Manufacturing, Industrial Technology, Business, or a related degree (based upon departmental requirements) and 2 years of leadership experience (preferably in a GMP / pharma environment). Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
    $30k-38k yearly est. 60d+ ago
  • Sr. Financial Analyst

    Hikma Pharmaceuticals USA Inc. 4.9company rating

    Hikma Pharmaceuticals USA Inc. job in Dayton, OH

    Job Type: Full-Time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760* high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians, and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our 30 manufacturing plants, 9 R&D centers, and 9,100+ empowered employees globally, we are committed to making high-quality medicines accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Senior Financial Analyst to join our team. In this role, you will be responsible for carrying out the general finance tasks of the Hikma's 503b business. The responsibilities include monitoring of operating expenses, preparing budgeting & forecasting, controlling of inventories, product costing, management reporting, purchase requests approval, managing CAPEX spending, in addition to business partnering. It does includes support others site mainly Cherry Hill. Responsibilities: Operating Expenses: Reporting and monitoring of the site operational spending. Financial Planning & Analysis: Conducting the budgeting, forecasting and business planning exercises for all operational Expenses, capital spend as well as commercial sales forecast. In addition to management reporting, that include preparing weekly and monthly management reports that measure the company performance. Inventory Control: ensuring financial reporting accuracy of Inventories while analyzing the balances and ensuring the company inventory reserves are adequate per company policy. This includes monitor the supply chain ERP (ASCtrac) and reconcile the quantities against the company ERP (SAP) Product Costing Standards: Supporting the product costing exercise for the site on a yearly basis for the whole portfolio, for specific products as needed, and for new launches. Capital Expenses: Monitoring the site CAPEX Budget while continuously managing the spend per project. Qualifications: Bachelor's Degree in Finance or Accounting. Master's degree/MBA preferred. 3+ years of finance / Accounting experience. Strong quantitative analytical skills and experience in utilizing data to influence decision making. Excellent communication skills, including both verbal and written. Outstanding financial modeling and critical thinking skills. Excellent problem solving and project management skills. Ability to build relationships at all levels to manage the departmental relationship with numerous stakeholders. Strong experience both in working effectively within a matrixed environment and building alignment in a cross functional environment. Excellent Excel, PowerPoint, and Presentation skills. Knowledge in ERP systems: SAP, ASCtrac preferred Compensation: Base Salary: $66,600 to $95,000 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries. 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards programs Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. Agency Notice: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.
    $66.6k-95k yearly 59d ago
  • Summer Internship - Supply Chain

    Hikma Pharmaceuticals 4.9company rating

    Hikma Pharmaceuticals job in Columbus, OH

    Job Title: Intern - Supply Chain Job Type: Intern Compensation: $19.00/hour Internship will commence in May and end no later than August. About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We are seeking a motivated and detail-oriented Supply Chain Intern to join our Materials Warehouse team. This internship offers a unique opportunity for hands-on experience supporting Warehouse Management System (WMS) activities, materials flow, and high‑volume handling system (HWS) design and efficiency initiatives. The intern will work on real-world materials management and inventory control projects with a focus on process optimization and Lean Six Sigma principles. The ideal candidate will be eager to learn, analyze, and interested in improving materials flow, system performance, and operational efficiency. Responsibilities: * The intern will work on various optimization projects. * Assist with a variety of supply chain optimization activities, including work related to inventory settings, planning processes, reporting, and general operational improvements. * Support cross-functional projects by gathering data, documenting processes, and contributing to updates that enhance efficiency, accuracy, and consistency within the supply chain function. * Supply Chain department support * Support WMS-related materials management activities, including inventory transactions, material movements, and process documentation * Assist with HWS design, workstation layout, and efficiency analysis to improve materials flow, throughput, and labor productivity * Participate in process optimization initiatives using Lean Six Sigma tools such as process mapping, root cause analysis, and standard work * Collect, analyze, and organize data related to inventory accuracy, material availability, and operational efficiency * Provide general support to the Materials Management function, including continuous improvement and system optimization efforts * This internship provides an excellent platform for a supply chain student to develop practical skills in materials management, WMS functionality, system and workstation design, and Lean Six Sigma methodologies while contributing to impactful operational projects * Other activities as assigned Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: * Regular and predictable onsite attendance and punctuality. * Completion of at least one year of college coursework toward a degree in Supply Chain Management, Operations Management, Industrial Engineering, Logistics, or a related field. * Must be an Undergraduate, Graduate, or Professional Student in good academic standing. * Completion of a minimum of 12 credit hours within a related major and/or relevant coursework such as materials management, inventory control, operations, or systems analysis. * Demonstrated interest in materials management, WMS functionality, and process flow optimization. * Preferred exposure to or interest in Lean Six Sigma concepts, continuous improvement, or process analysis methodologies. * Strong analytical and problem-solving skills with the ability to interpret operational and system data. * Ability to work independently and manage multiple tasks simultaneously in a hands-on operational environment. * Strong organizational skills with a high level of attention to detail. * Effective planning and time-management skills. * Proficiency in Microsoft Office applications (Excel, Word, PowerPoint required; data analysis experience a plus). * Strong verbal and written communication skills, with the ability to communicate clearly with cross-functional teams. * Demonstrated initiative, positive attitude, and willingness to learn and support the Materials Management team. * Ability to wear required personal protective equipment (PPE) and work in an operational environment as needed. * Must be legally authorized to work in the United States without restriction; no sponsorship offered at this time. * Must be willing to submit to a background investigation, including verification of employment, criminal history, and educational background. * Must be willing to take a drug test. * Must be 18 years of age or older. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. #LI-KJ1 Location: Columbus, OH, US, 43228 Nearest Major Market: Columbus
    $19 hourly Auto-Apply 4d ago
  • Logistics Technician

    Hikma Pharmaceuticals 4.9company rating

    Hikma Pharmaceuticals job in Lockbourne, OH

    Job Title: Logistics Technician Job Type: Full-time, Starting rate is $21.00 an hour If working 2nd or 3rd shift, there is an additional 10% shift differential awarded About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' mission is to bring Better Health. Within Reach. Every Day. for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 750 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Logistics Technician to join our team. In this role, you will be responsible for Under the guidance of management, and with the task direction of Team Leaders, the Logistics Technician position is responsible for the receipt, storage, processing, and shipping of materials in support of production and to engage in distribution activities for a multi-company, multi-divisional corporate warehousing/distribution center. This is done in a team-based environment by working closely with others for the common goals of the department. All duties are performed in compliance with all Government, Company and Departmental Operating Polices & Procedures. Key Responsibilities: * Accurately pick, pack, stage, scale, and load customer orders for external/internal movement and prepare all pertinent documentation. * Accurately receive and put away incoming products and supplies, update SAP and document any discrepancies. * Load and unload trucks safely and complete all documentation properly. * Contact Carriers and coordinate pickups and deliveries. * Monitor and maintain adequate supply of operating supplies. Perform clean up and light maintenance duties to maintain a high standard of housekeeping. * Store, Retrieve and Transact, material moves to and from storage bays and replenish storage bins. * Select and Print deliveries and report any material issues pertaining to order fulfillment as required. * Actively participate in and complete all company training programs for DP's, SOP's, Company Policies, and Safety programs demonstrating learned knowledge on a daily basis. * Check the accuracy of documents to ensure the proper movement of inventory. Verify the accuracy of inventory by checking the documentation and/or conducting inventory cycle counts. * Actively participate in all Company and Departmental meetings, (Job Boards, Performance Centers, MTZ, etc.) Prepare pertinent documentation for exports, process orders, shipping memos, etc. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: * High school diploma or GED. (required) * 1 year experience in a warehouse and/or distribution environment including order processing, inventory control and receipts. (preferred) * OSHA Industrial truck certification. (preferred) * Operate warehouse industrial material handling equipment as required, Pallet Jacks, Pallet Transfer, High cube, ASRS, Shrink Bundler, Strapping Machines, Shrink Wrapper, Pallet Scales, Conveyor etc. * Familiarity with MS Office products (specifically Word, Outlook, and Excel), and SAP or equivalent systems. (preferred) * Must have reliable transportation as position requires working at warehousing facilities located at multiple sites. * Ability to learn and apply all relevant Department Procedures (DPs), Standard Operating Procedures (SOPs), and other regulatory requirements. * Ability to read information and apply what was described in the reading material to situations which may contain several details or describe processes involving several steps. * Ability to effectively communicate both verbally and in writing to peers and management. * Ability to use computers to perform a variety of data-entry transactions, perform, RF transactions and to retrieve information (procedures; safety, employment, and other information). * Demonstrated ability to perform basic math functions using a calculator (add, subtract, multiply, divide, rounding, etc.). * Demonstrated high level of personal motivation and initiative and be able to work independently to complete daily tasks assigned. * Ability to adapt and be flexible with daily work assignment changes as well as a continuously improving work environment. * Ability and willingness to maintain accurate and factual hard-copy and electronic records. * Demonstrated ability and willingness to work and participate effectively in a team environment. * Ability and willingness to follow directions, as assigned by management, coaches, peers, or in written instructions. * Attention to detail, safety, quality and customer requirements. * Ability to make independent decisions within the scope of operating policies and procedures. * Strong interpersonal effectiveness and leadership skills in order to mentor others. * Overtime might be required for this position. * Able to lift and carry 50 pounds occasionally. * Able to lift 35 pounds overhead occasionally. * Able to stand/walk 6-7 hours per shift. * Able to push/pull 65 pounds occasionally. What We Offer*: * Annual performance bonus, commission, and share potential * Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute * A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries * 3 personal days (prorated based on hire date) * 11 company paid holidays * Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits * Employee discount program * Wellbeing rewards program * Safety and Quality is a top organizational priority * Career advancement and growth opportunities * Tuition reimbursement * Paid maternity and parental leave * Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. Location: Lockbourne, OH, US Columbus, OH, US, 43228 Nearest Major Market: Columbus
    $21 hourly Auto-Apply 60d+ ago
  • Maintenance Reliability Technician (MRT) (Various Shifts)

    Hikma Pharmaceuticals 4.9company rating

    Hikma Pharmaceuticals job in Columbus, OH

    Job Type: Full-Time Compensation: Starting hourly rate is $24.00 (Compensation will be determined based on relevant experience for the role). PLUS Shift differential for working 2nd, 3rd shift and weekend shifts. About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Maintenance Reliability Technician to join our team. In this role, you will be responsible for maintaining manufacturing, packaging, and/or site facility equipment by troubleshooting, adjusting, repairing, rebuilding, and replacing components to ensure equipment performance is reliable. Performs analysis of failures with support of other experienced MRT's, Team Lead, Engineer and/or Optimizer. Perform preventive, corrective, or emergency work orders and respond to service calls while the plant is in operation, which may include off-shift periods and weekends. Manufacturing equipment includes (but not limited to) equipment such as Fluid Bed Dryers, Granulators, Tumblers, Compactors, Tablet Presses, Encapsulators, Tanks, Pumps, Valves, Isolators, and various other process equipment. Packaging equipment includes (but not limited to) equipment such as Bottle Blower/Erectors, Tablet/Capsule Fillers, Liquid Fillers, Thermoformers, Water Chillers, Cartoner, Sealers, Checkweighers, Labelers, Printers, and various other process equipment. Site facility equipment includes (but not limited to) HVAC, building automation, chilled water systems, boiler systems, water purification systems, compressed air systems, or plumbing systems. Key Responsibilities: * Provides experienced service and technical expertise by maintaining manufacturing, packaging and/or site facility equipment. Completes predictive, preventive, and reactive work in support of reliable and efficient equipment. * Experienced service includes troubleshooting and repairs to various equipment that require some decision making to determine business impact including prioritizing, cost-consciousness, and lead time. * Supports continuous improvement by completing work on time, identifying potential issues and execute improvements, and driving to improve work processes and procedures relative to manufacturing, packaging and/or site facility equipment. * Monitors the manufacturing, packaging, and/or site facility areas and related equipment to identify problems or opportunities and identify root cause and remediation of failures either independently or with support of others for repairs or process improvements to efficiency and/or reliability of manufacturing, packaging, and/or site facility equipment. * Communicates regularly with other MRT's, Team Lead, Coach and customers regarding the state of the equipment, status of work, known problems, and improvement initiatives. * Maintains and ensures documentation, both written and electronic, is accurate, complete and factual as required by policies, procedures, and regulatory guidelines. Documents activities supporting maintenance best practices to ensure that continuous improvement activities have adequate and reliable data for analysis. Partners in the periodic development, review and modification of preventative maintenance, work instructions or other related procedures and methods, based on detailed specifications, drawings, and other technical requirements. * Works with Optimizers and Engineers on projects and improvement initiatives to ensure equipment meets site standards, this may include support for Factory Acceptance Testing (FAT) or Site Acceptance Testing (SAT) and related travel. Execute test protocols in support of the qualification of new and existing equipment. Reviews project designs and make recommendations for equipment accessibility and reliability. Consults with other experienced MRT's, Team Lead, Process Coach, or Engineer/Optimizer and communicate results and facilitate proper hand-off from project team to long-term process and/or equipment owners. * Actively participates in and leads team initiatives such as 5S+1, continuous improvement activities (CIAs), maintenance best practice initiatives, and performance center (PC) meetings to identify and resolve manufacturing and/or packaging issues on a real-time basis. Provides input/suggestions to procedures, policies, work instructions and task sheets relating to maintenance and equipment certification. Maintains required tools, supplies, and work areas necessary for completing required maintenance tasks in area of responsibility in accordance with 5S+1 principles to ensure a safe and efficient work area and to eliminate clutter and foreign particles that could potentially damage equipment or product. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: * High School Diploma (or equivalent). * Specialized education or training in mechanical maintenance or related field. * 2-years repairs with basic maintenance of industrial equipment; including, but not limited to manufacturing or packaging equipment. Working knowledge of hydraulics, pneumatics, pumps, valves, belt/chain drive and gear boxes, clutches & brakes, fasteners, lubrication, bearings, seals & gaskets, etc. * Minimum of 4-years total experience in a technical field. The 2-year requirement above can be applied to this requirement. * A degree in a technical field or applicable military training may satisfy the "years experience" requirement. * On the job training in lieu of formal training, if technical competency can be demonstrated. * Demonstrated mechanical and technical aptitude. * Working knowledge of hand a power tool safety, selection and application. * Specialized tool skills (torque wrench, drill press, tap & die, etc.) * Demonstrated ability to effectively maintain, troubleshoot, and repair industrial equipment involving technical and mechanical issues (i.e. equipment adjustments, parts replacement). * Working knowledge of schematics, P&ID drawings, and ISA symbols & numbering. * Strong written and verbal communication skills, detail orientation and the ability to work independently or within a team environment. * Ability to use computers to perform a variety of data-entry transactions and to retrieve information (procedures; safety, employment, and other information). Must be able to use MS Office products (specifically Word, Outlook, and Excel), and perform data entry in CMMS or equivalent systems. * Demonstrated ability and willingness to maintain accurate records. * Demonstrated ability to learn and apply all relevant Work Instructions and Standard Operating Procedures and other regulatory requirements. * Ability and willingness to follow directions, as assigned by management, team lead, or in written instructions. * Attention to detail, safety, quality and customer requirements. * Demonstrate a high level of personal motivation and initiative. * Ability to adapt and be flexible with daily work assignment changes as well as a continuously improving work environment. * Ability to work off-shifts and weekends due to business needs. * Ability to be on-call and available on site within set time guidelines. * Able to climb a 6 foot ladder. Preferred Qualifications: * Specialized troubleshooting or education; certification from an accredited organization or society. * Experience with complex technical equipment. What We Offer*: * Annual performance bonus, commission, and share potential * Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute * A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries * 3 personal days (prorated based on hire date) * 11 company paid holidays * Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits * Employee discount program * Wellbeing rewards program * Safety and Quality is a top organizational priority * Career advancement and growth opportunities * Tuition reimbursement * Paid maternity and parental leave * Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. #LI-KJ1 Location: Columbus, OH, US, 43228 Nearest Major Market: Columbus
    $24 hourly Auto-Apply 60d+ ago
  • Manager, Quality Assurance

    Hikma Pharmaceuticals USA Inc. 4.9company rating

    Hikma Pharmaceuticals USA Inc. job in Dayton, OH

    Job Title: Manager, Quality Assurance Job Type: Full-Time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Quality Assurance Manager to join our team. In this role, you will be responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that products are manufactured in compliance with cGMP guidelines, USP and FDA, EU requirements. In addition, you will be responsible to direct batch record review, control and release, handle investigation process (CAPA) assuring that any discrepancies are investigated thoroughly and in a timely manner. Key Responsibilities: Regular and predictable onsite attendance and punctuality. Directs the batch record review process. Makes final accept/reject disposition on product lots. Assures batch is manufactured in compliance with NDA/ANDA/EU, cGMP and Validation parameters. Ensures that records are reviewed and released in a timely manner. Coordinates communication for status of lots and status of and resolves issues related to accept/reject disposition of batches. Places lots on HOLD if Quality issues are detected and notifies senior management. Coordinates destruction of rejected finished goods and assures destruction occurs in a timely manner. Expedites and prioritizes product releases by coordinating the Review, testing, and releases with site management to meet customer service requirements. Conducts routine investigation and departmental meetings to facilitate the performance of release function. Manages personnel for in-process filling and inspection/packaging monitoring Provide QA oversight of Operation for the entire Manufacturing process, supporting Clean room technicians and production technicians as needed to identify and address product quality compliance issues as they arise. Provide training and assistance to all Clean room and operation personnel for NCR, CAPA and Change Control. Provides QA review and approval of manufacturing investigations assuring timely review, follow-up, tracking and trending of MIRs. Perform Root Cause analysis and assure corrective action (CAPA) implementation associated with manufacturing investigations. Provide guidance to the investigation scientists on reporting and metrics required for different levels within organization. Performs QA review and approval of LIR's (Laboratory Investigation Reports). Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. Establish a qualification and Requalification program for Clean Room Certification and Recertification, for ISO 5 and 7 environments. Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. Assists the QA management in developing on department budget. Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. Manages attendance records for all direct reports. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: Minimum: Bachelor's degree in Pharmacy, Biology, Chemistry or a related field Preferred are beneficial [List the required qualifications such as education, skills, and experience] Preferred Qualifications: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management Skills: Must have history of strong documentation skills and attention to detail Familiarity with cGMPs and CFR for US and EU Excellent organizational skills and ability to multi-task and perform work in a timely manner Demonstrates ability to lead a department, projects and meetings effectively Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management General computer skills and ability to prepare presentations and address large groups Demonstrated attention to details and accuracy The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must Compensation: Base Salary: $92,850 to $158,450 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
    $92.9k-158.5k yearly 44d ago

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West-Ward Pharmaceuticals may also be known as or be related to Hikma Pharmaceuticals USA Inc., WEST WARD PHARMACEUTICAL CORP., West-Ward Pharmaceutical Corp, West-Ward Pharmaceutical Corp., West-Ward Pharmaceuticals and West-ward Pharmaceuticals.