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CSL Plasma jobs in Raleigh, NC

- 104 jobs
  • Director, EHS & Risk Management

    CSL Plasma 4.6company rating

    CSL Plasma job in Holly Springs, NC

    Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day. As the Director of EHS and Risk Management, you will be reporting to the Senior Director. This role is accountable for providing leadership and the strategic execution for Environmental, Health, Safety and Sustainability. Responsibilities include execution of the EHS strategy, driving behavioral and cultural change, and the continuous improvement of EHS practices in alignment with CSL standards and values, regulatory requirements and industry best practices. Benefits include eligibility for an annual bonus, Onsite Café, walking trail and other outdoor amenities, Medical, Dental, Vision, Life Insurance, 401K with a 6% match, and PTO available from your first day of hire. Responsibilities Lead, manage and develop the EHS staff ensuring appropriate organizational structure, staffing, skills, technical knowledge and prioritization of work to support our goals and compliance. Develop talent and bench strength for current and future business needs. Lead the site safety culture and development of an environmentally conscious culture and with site leadership team executes strategies and monitors and continuously improves the sites EHS Culture. Ensure an on-going state of compliance with all applicable EHS regulations. Provides expert support to outside EHS regulatory agencies. Develop and implement plans to ensure site conformance with the Global EHS Management System requirements similar or equivalent to ISO 45001, VPP, or ISO 14001. Actively drive programs to ensure systems are effective and efficiently in implementation and use. As a member of the Site Leadership Team, actively contributes to the development and implementation of the broad enterprise strategy, culture and governance processes. Help manage significant EHS risks through the site and business unit risk management processes and risk registers. Oversee the effectiveness of emergency preparedness processes. Engage and contribute to EHS Global process development and implementation. Proficient in the development of strategies, objectives, and plans to achieve long-term and short-term goals. Extended experience in a manufacturing or similar related function, Experience reporting to government and other regulatory authorities. Demonstrated experience in leading and managing teams. Experience leading, promoting and operating in a collaborative work environment. Extended experience in a manufacturing or similar related function, Experience in reporting to government and other regulatory authorities including regulatory audits Minimum Qualifications Bachelor's degree in Occupational Safety, Environmental Engineering, Environmental Sciences, Chemical Engineering or equivalent 10 years of EH&S experience or equivalent experience 5+ years leading teams or direct people management is preferred Experience leading EHS for a site/facility in a GMP or biological manufacturing environment a plus Experience working in a large pharmaceutical or chemical manufacturing experience is a plus Prior experience with developing and delivering presentations to audiences of 25 to 200 people (examples include providing updates at functional all-staff meetings and presentations of data or results) Knowledge of relevant local, state and federal regulations #LI-Oniste Our Benefits CSL Seqirus employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL Seqirus offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL Seqirus has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL Seqirus employee. About CSL Seqirus CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world. We want CSL Seqirus to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL. Do work that matters at CSL Seqirus! Watch our ‘On the Front Line' video to learn more about CSL Seqirus
    $107k-150k yearly est. Auto-Apply 60d+ ago
  • Holly Springs Communications Intern

    CSL Plasma 4.6company rating

    CSL Plasma job in Holly Springs, NC

    2026 Communications Intern Hiring Manager Name: Jennifer Bailey CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL - including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor - provides lifesaving products to patients in more than 100 countries and employs 29,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. Program Experience CSL's Internship Program is a hands-on experience that showcases the daily innovation and operations of a leading biotechnology company. Our environment is collaborative, global, and purpose-driven. The experience immerses students in meaningful, thought-provoking projects that contribute to CSL's promise to save lives and protect the health of people around the world. In addition to making an impact, students will be developed personally and professionally while cultivating meaningful relationships. Main Responsibilities This role will be located in Holly Springs, North Carolina. • Content Development: Produce a variety of content using copyrighting, graphics and/or video. This may include interviewing employees, taking pictures, writing articles, recording videos, and/or securing necessary internal approvals. Content will be used across multiple channels, including email, our internal news site, site screens, posters and more. o The majority of support will be provided for the Holly Springs site, but there may be requests to support regional or global initiatives. • Communication Production & Distribution: Produce and distribute sitewide email communications and site screens.. • Event Planning & Execution: Assist with preparation for and implementation of employee engagement initiatives and other special events. • Stay Informed: Stay up-to-date with the latest advancements in the field of communications and integrate new techniques where appropriate. • Professional Development: Engage in learning opportunities offered during the internship. Network with other members of the Holly Springs and Corporate and External Affairs teams to gain insights and career advice. Qualifications: • Enrolled in a 4-year university with progression toward an undergraduate degree in Communications, Journalism or related major • Demonstrates strong analytical and quantitative skills • Excellent communication and presentation skills • Able to manage multiple priorities, is a self-starter and keen on knowing when to work independently and collaboratively • Ability to work well with all levels of the organization • Demonstrates flexibility and acceptance of assignments and schedules • Enthusiasm to learn new tools & technologies • Maintains professional behavior CSL will provide equal employment opportunity for all persons without discrimination on the basis of membership in a legally protected class, including race, color, religion, national origin, gender, age, veteran status, or handicap/disability. CSL is committed to ensuring that diversity and inclusion are a part of our everyday business. About CSL Seqirus CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at *************************** Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement. Watch our ‘On the Front Line' video to learn more about CSL Seqirus
    $28k-38k yearly est. Auto-Apply 6d ago
  • Administrative Associate

    Grifols Sa 4.2company rating

    Raleigh, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. This is a hybrid position with 1 day from home with an option for additional days in the future. Summary: Perform responsible administrative duties of a complex and confidential nature in support of major departmental or divisional activities to relieve supervisor of varied clerical and administrative responsibilities and to maintain efficiency of organizational operations. Job Responsibilities: * Perform advanced, diversified and confidential administrative duties by independently coordinating meetings, preparing agendas; completing a variety of non-routine tasks; coordinating department schedules, recording meeting minutes, arranging for management travel and time management; serve as primary liaison for executive and other senior management. * Support the daily operations of department, division or other organization unit assigned by assisting in meeting administrative goals and priorities for both short and long-term projects and monitoring day to day operations for efficiency and productivity. * Develop organizational unit calendar to define milestones and develop action plans to deliver milestones in a cohesive, thoroughly vetted manner which is met with great acceptance and understanding * Develop and distribute all department correspondence and information. Screen and route mail and documents; determine which to respond to, which to redirect or which to bring to supervisor's attention based on content of communication and broad knowledge of departmental programs and activities. * Organize and maintain divisional or departmental files of records, reports and correspondence required for reference and efficient operation of division or department; maintain up-to-date management and procedural manuals, directives and related records; interpret new directives, policies and regulations and inform appropriate personnel of changes * Process a considerable amount of confidential and sensitive information in support of administrative activities * Assist in preparing moderately to extremely complex reports and proposals requiring the identification of sources, compilation, analysis and evaluation of data. * Review reports received for supervisor; check and compare with source documents and bring significant items, changes, errors or omissions to the attention of the supervisor. * Assist in the preparation and management of diversified department, making suggestions and projections based on knowledge of departmental operations. * Compose letters and statements independently requiring interpretation and application of departmental policies, procedures, rules and regulations; type letters, reports and records ensuring grammatical accuracy, conformance with general policy and factual correctness. Knowledge, Skills, and Abilities: * Works on assignments that are complex in nature in which considerable judgement and initiative are required in resolving problems and making recommendations. * Capable of operating at the Board levels when asked to. * Work requires a specialized administrative support experience, arithmetic skills the ability to use automated office equipment, read difficult instructions and maintain written records. * Also need broad knowledge of administration and practices normally acquired through two to four years of post-secondary education in secretarial science or a related business field. * Ability to score at least to the 90% proficiency level on advanced office applications and procedures using the various assessment tools at Grifols. * Excellent customer service skills. * Demonstrated ability to build rapport with internal and external customers; ability to prioritize workload. * Accuracy of work; Sense of Urgency for time sensitive projects. * Ability to seek guidance when answer is not clear; Receptive to feedback from others. * Teamwork, Attendance, Professionalism, Excellent Phone Demeanor Required. * Takes on other assignments willingly; Takes on stretch projects. * Displays proficiency in MS Office Suite at an advanced level and excels/subject matter expert in at least one software app. or area. * Computer skills with test scores at least 90% on advanced level in MS Office. * Takes on other assignments willingly; Takes on stretch projects. * Makes best use of time; offers to assist others in department during down time. * Seeks to increase skills. Asks for stretch assignments. * Others see as a "go to resource". * Collaboration within department as well as within other departments. Education and Experience: * AS Degree and 5 years of relative experience showing increasing administrative responsibility or BS Degree and 2 yrs of relative experience showing increasing administrative responsibility * Working towards the Administrative Professional certification or an equivalent combination of relevant education and/or experience. This position is eligible to participate in up to 5% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years - we're growing, and you can grow with us! #biomatusa Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : NC-RTP:USNC0001 - RTP NC-Headquarters
    $21k-30k yearly est. 60d+ ago
  • Assistant/Associate Biologist

    Grifols Shared Services North America, Inc. 4.2company rating

    Clayton, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. **Hours:** 12 Hour Shift ; 6:00 PM- 6:00 AM ; rotating shift; (Training will take place on 1st shift the first 1 month) Week 1: M, T, F, Sat. Week 2: Su., W, Th. **Location:** Clayton This position is responsible for performing environmental monitoring on classified areas and utility systems. Depending on area of assignment, responsibilities will include the collecting and/or testing of environmental, utility, raw material, or validation samples utilizing test methods that are specific to the assigned laboratory. Candidates must be able to follow the requirements of Grifols, Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP) and complete work in a safe, accurate, and efficient manner. Responsibilities will also include performing non-routine duties, housekeeping duties, etc. as well as participating in projects such as standard and control preparations, method validations, comparison studies, etc. **Requirements** The Assistant level requires an AA or BS degree in medical technology/clinical laboratory science, or a BS degree in biology, chemistry, or related field in addition to 6-12 months of applicable laboratory experience. A background in medical technology / clinical laboratory science is preferred, as is experience in a GLP / GMP laboratory The Associate level requires an AA or BS degree in medical technology/clinical laboratory science, or a BS degree in biology, chemistry or related field in addition to 2 years of applicable laboratory experience. A background in medical technology / clinical laboratory science is preferred, as is experience in a GLP / GMP laboratory. Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.** **Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton** Learn more about Grifols (************************************** **Req ID:** 536768 **Type:** Regular Full-Time **Job Category:** TECHNICAL
    $36k-78k yearly est. 27d ago
  • Clinical Quality Assurance (CQA) Quality Control & Process Specialist

    Grifols Sa 4.2company rating

    Raleigh, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Primary Responsibilities: * Participate in the development and review of the Clinical SOPs, Regulatory documents and Study Plans * Participate in the Clinical SOPs periodic reviews as well as in the creation of new procedures * Participate in the study plans reviews * Participate in the review of Regulatory Documents (Clinical Study Protocol, Investigators Brochure, Informed Consent Form, Clinica Study Report) * Provide quality oversight on the conduct of the clinical studies * Perform periodic quality reviews of the critical clinical procedures on the different clinical studies * Interact with Drug Development department to provide guidance and consultancy to resolve compliance issues * Coordinate the management of study, internal and vendor deviations * Participate in the review of critical protocol deviations and Serious Breaches * Participate in project team internal meetings providing information about quality metrics of studies * Collaborate in the development of the Quality Risk Management Assessment of the different clinical studies * Initiate the Quality Risk Assessment for every clinical study * Qualification and periodic assessment of clinical and pharmacovigilance vendors participating in the clinical studies * Perform a quality assessment (including a risk assessment) of all the vendors selected as candidates to participate in the clinical studies * Qualify the clinical vendors before their participation in the clinical studies and re-qualify them when applicable * Perform an annual assessment of the performance and compliance of the vendors participating in the clinical studies Requirements: * Life Sciences Degree. * A minimum of 5 years in a similar role or provide experience in Quality and Clinical Trials. * Ability and willingness to travel. * Ability to work both in a team and independently. * Ability to meet deadlines, multitasks, and prioritize based on study needs. * Ability to works on assignments with a diverse scope. * Ability to work with a very limited direct supervision. * Advanced knowledge of ICH/GCP Guideline. * Advanced knowledge of electronic data capture (EDC) systems. * Advanced knowledge of medical terminology. * Advanced knowledge of the therapeutic areas assigned. * Routinely demonstrates mastery of technical skills Occupational Demands Form: Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : NC-RTP:[[cust_building]]
    $56k-92k yearly est. 42d ago
  • Sr. Operations Supervisor

    Grifols Sa 4.2company rating

    Goldsboro, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Summary: The Senior Operations Supervisor plays a critical leadership role in the day-to-day operations of the plasma donor center. As a senior frontline leader, this role is responsible for overseeing the daily activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts as a lead resource during shifts, ensures execution of operational priorities, and provides direct support to the Center Manager in driving performance, donor satisfaction, and continuous improvement. Primary Responsibilities * Serves as acting leader in the absence of the Center Manager as assigned. Maintains the ability to perform any/all tasks within the plasma center; fulfill the role of production employees and supervisor donor flow * Oversees donor operations and supervise Operation Supervisor(s) and donor center staff during assigned shifts. This includes provide shift leadership, including staffing coordination, task assignments, break schedules, and coaching of team members. * Creates employee schedules to accommodate donor cycles. * Determines the adequacy and adjust inventory levels of all goods and supplies necessary of the operation of the donor center. Compile and submit orders to vendors to meet determined inventory levels * Keeps Center Manager informed of any irregularities within the center and provide action plans to improve and correct center deficiencies. * Supports and executes daily operational plans to achieve center performance targets related to donor throughput, quality, and productivity. * Partners with Center Manager and Quality team to identify and resolve deviations or operational concerns in real time. * Monitors donor flow and proactively address delays or service issues to ensure an exceptional donor experience. * Oversees donor floor operations and supervise operation supervisor(s) and donor center staff during assigned shifts. * Learns and maintains thorough familiarity and compliance with all state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP) and internal company procedures. * Supervises donor selection, plasma collection and all manufacturing records to maintain the highest production standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP. * Attends all required training sessions, staff meetings, etc. * Ensures that accurate and thorough documentation of necessary records is performed. * Under the guidance of the Center Manager assure facility is maintained in a neat and clean condition and all equipment is kept in good working order. * Submits timely and accurate reports as required by the Center Manager * Assists in the control of center donor funds as determined by the Center Manager * Participates in the onboarding, training, and cross-training of staff to support center agility and performance. * Maintains active communication with other service areas to ensure accurate documentation and quality. * Leads by example in promoting a culture of safety, teamwork, and accountability. * Reports all unsafe situations or conditions to area lead, supervisor or manager. * May be trained to repair plasma center equipment. * Assists the Center Manager in any task necessary in pursuit of company objectives. This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed. Education: High school diploma or GED. Certified as a Phlebotomist, Donor Center Technician, Plasma Processor, and Designated Trainer. CPR Certified Experience: Typically requires 6 years of related experience with performing phlebotomy, donor processing, and plasma processing duties with demonstrated proficiency to handle difficult situations. Equivalency: Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level typically requires an Associate's degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor's degree. Knowledge | Skills | Abilities Exceptional customer service skills. Proficient in speaking and writing English, with legible handwriting. Where applicable, bi-lingual skills. Ability to understand, explain, and follow SOP's and protocols. Ability to work flexible scheduling to meet business needs. Ability to perform in a highly regulated, operations intensive, high volume medical business in which the safety of donors and employees, as well as the quality of the plasma collected, are paramount. Occupational Demands Form # 73: Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing functions in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves, and cold gear. Work is performed both standing for up to 4 to 6 hours per day and sitting 1 to 2 hours per day each. The position does require bending and twisting of neck up from 1 to 2 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement; may squat, crouch, or sit on one's heels on rare occasion. Infrequently bends and twists at waist. Light lifting of 15lbs. with a maximum lift of 50lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently and within guidance of oral or written instructions. Performs a wide range of tasks as dictated by variable demands and changing conditions. Relates sensitive information to diverse groups. #biomatusa #app #LI-CM1 Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : NC-Goldsboro:[[cust_building]]
    $49k-91k yearly est. 60d+ ago
  • Packaging Technician I/II 2nd Shift

    Grifols Shared Services North America, Inc. 4.2company rating

    Clayton, NC job

    Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions. Packaging Tech 1 / Packaging Tech 2 Hours: **2nd** **shift** ( **Mon - Thurs / 3:30 pm - 2:00 am)** **Summary:** The Packaging Technician 1 & 2 responsibilities are to detect and identify defect trends during the inspection of manufactured products. Accurately inspecting and selecting product samples for both routine and non-routine quality and stability testing. Performing labeling activities and to verify product and diluent vial labeling used in the packaging of biological products for accuracy. The Packaging Technician 2 responsibilities are to detect and identify defect trends during the inspection of manufactured products. Accurately inspecting and selecting product samples for both routine and non-routine quality and stability testing. Performing labeling activities and to verify product and diluent vial labeling used in the packaging of biological products for accuracy. **Packaging Tech 1:** + Perform paced inspections of final container products for multiple categories of defects. + Document job tasks as required on the Batch Production Record (BPR), Standard Operating Procedure (SOP) document or other acceptable form(s). + Perform housekeeping tasks and maintain department housekeeping at an optimal level. + Adhere to all company safety and cGMP policies and practices. + Meet and maintain visual inspection recertification requirements through knowledge of the PDA Lexicon for glass defects and the in-house training and certification standards. + Other duties as assigned. Additional Packaging Technician duties: Set-up, operate and troubleshoot various packaging equipment; Manually package products; Inspect packaged and pre-packaged products for possible defects; Conduct an accurate count of pre and post packaged products; May off load and load products from cages, carts, and boxes; and May operate material handling equipment such as pallet jacks, forklifts, etc. In Grade Salary Adjustment Requirements: Set-up and operate multiple label verification vision systems on vial labelers and cartoners. Set-up and operate multiple vial labelers, vial cartoners, shrink banding machines and other equipment related to final container labeling. Conduct periodic challenges for the various packaging systems. **Knowledge Skills and Abilities:** Able to work effectively as a member of a team. Must pass annual vision testing for near vision and colorblindness. Must be able to pass initial visual inspection certification within 90 days of hire date. Able to identify product defects in accordance with the PDA Lexicon for glass defects and other applicable SOPs. Must be capable of maintaining continuous and concentrated focus on assigned tasks during packaging activities. **Requirements: Tech 1 - Education/Experience: High School Diploma. Packaging Operator/Inspector experience preferred** **Packaging Tech 2:** + Perform duties associated with the Packaging Tech I level + Troubleshoot, maintain and do changeover for Packaging equipment. + Qualified to set up and operate Packaging equipment (e.g. serialization equipment , vial labelers, cartoners, shrinkbanding machines, etc.) + Deliver samples to various Quality Laboratories for required testing. + Operate a computer to review and /or enter data into a variety of systems including but not limited to LIMS, SAP, etc + Must possess and maintain knowledge of various product specifications in order to ensure that correct components are used. + Evaluate the cause of rejected labeling and document findings according to SOPs. **Knowledge Skills and Abilities:** Able to work effectively as a member of a team. Must pass annual vision testing for near vision and colorblindness. Must be able to pass initial visual inspection certification within 90 days of hire date. Able to identify product defects in accordance with the PDA Lexicon for glass defects and other applicable SOPs. Must be capable of maintaining continuous and concentrated focus on assigned tasks during packaging activities. **Requirements: Tech 2 -** Education: HS Diploma. Experience: 1-year Packaging Inspector/Label Verification Tech experience preferably obtained in a pharmaceutical or biotech environment. Work is performed in a manufacturing environment with rotating shifts. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to chemicals, electrical manufacturing equipment, hand tools and moving machinery. Exposure to high levels of noise and to extreme cold below 32*. Exposure to office electrical equipment. Personal protective equipment required such as protective eyewear, safety shoes, gloves and garments. Occasionally enters into confined spaces requiring squatting, kneeling or climbing. Work is performed standing for 6-8 hours per day with frequent walking. Frequent hand movement of 4-6 hours at one time of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light lifting and carrying of 15lbs. for 6-8 hours per day. Moderate lifting and carrying of 15-44lbs for 4-6 hours per day with a maximum lift of 45lbs. Occasionally bends and twists neck and waist. Occasionally reaches above and below shoulder height. Frequent foot movements. Hearing acuity essential. Color perception/discrimination, near and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently performs routine tasks that vary little each day by following a set of written or oral instructions/procedures. Learn more about Grifols (************************************************* **Req ID:** 537221 **Type:** Regular Full-Time **Job Category:** MANUFACTURING
    $32k-41k yearly est. 8d ago
  • Quality Assistant/Associate Materials Evaluation Coordinator

    Grifols Shared Services North America, Inc. 4.2company rating

    Clayton, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Frist Shift **Quality Assistant/Associate Materials Evaluation Coordinator** **Summary:** The Quality Operations (QO) Assistant/Associate Materials Evaluation Coordinator evaluates critical quality attributes (visual, dimensional, functioncoordinates required chemical and/or biological testing, and executes approved usage decisions on all quality managed material used at the facility These evaluations are performed on a wide variety of materials including, but not limited to, chemicals, labeling components, primary drug containcomponents, process hoses, sterilizing filters, and other critical raw materials. This is done by verifying compliance to specifications and testingrequirements and ensuring required documentation is complete and accurate thus minimizing the possibility that the safety and efficacy of finalproducts manufactured and tested using these quality managed materials is compromised or adulterated. The Coordinators perform the last detailreview of these materials prior to release for use thus sound judgment is essential. The QO Assistant/Associate Materials Evaluation Coordinatorinspects product final container reserve samples according to approved standard operating procedures. The QO Assistant/Associate Materials Evaluation Coordinator may perform in the Packaging area as a Quality representative for sampling, auditing,making Qualitydecisions. In this area, the QO Assistant/Associate Materials Evaluation Coordinator audits final product batches using designatedsampling plans. Additionally, the Packaging QO Coordinator responsibilities include: reserve sampling, post-pack identity sampling, packagingcommodity verification and reconciliation, line clearance verification, and stability sample inspection. Decisions made by QO Coordinators have major compliance and monetary implications for Grifols. **Primary Responsibilities:** + Evaluate critical quality attributes (visual, dimensional, functional), coordinate required chemical and/or biological testing, and execute appusage decisions on all quality managed material used at the facility. + Issue and track Incidents/Raw Material Reports(RMRs) for discrepant material and quarantine product per approved procedures that governdisposition of such discrepant material. + Must stay abreast of the rapidly changing requirements of various regulatory agencies. New policy changes from these groups has a definitimmediate impact on Materials Evaluation responsibilities and release of material to production.Responsible for reconciliation of all product released (i.e.. Labels, plasma, raw material components, etc.) Non-reconciliation of material coumeans for material or plasma product recall and will impact product market availability. + Must possess extensive knowledge of cGMP, company specifications and distribution operating procedures.Associate QO Materials Evaluation Release Coordinators will serve as trainers to new employees in all aspects of this position and areconsidered to be a Subject Matter Expert (SME). **Knowledge, Skills & Abilities:** The incumbent must possess keen assessment skills and the ability to distinguish insignificant deviations from significant deviations that jeopardiintegrity of the material to be released. The incumbent must be able to learn and understand the concepts of statistical sampling used in daily activ Computer skills are required. Must be able to read and understand technical drawings. Effective communication skills, including proper grammar, essential in order to report (both in writing and verbally) data and product impact. Must keep neat, accurate, and complete records of materialevaluations and release activities performed. Tactful human relation's skills are essential to achieve cooperation between business partners andcustomers. Incumbent must have prior inspection experience (i.e. manufacturing components, packaged goods, etc.) **Education:** Requires minimum of an Associates degree with an emphasis in sciences or mathematics or an equivalent combination of education and experiencacceptable. **Experience:** A minimum of one year of related experience, preferably as a QC Assistant Materials Evaluation, is required for the QC Associate Materials Evaluation position. Incumbent must have prior inspection experience (i.e. manufacturing components, etc.). **Equivalency:** Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competenciemay be considered in place of the stated requirements. Example: If a job level typically requires an Associate's degree plus 2 years of experience, equivalent could include 4 years of experience or a Bachelor's degree. **Occupational Demands:** When working with raw material chemicals, the incumbent must be able to wear all required safety equipment such as protective eyewear, garmentsgloves and able to work with limited supervision. Must demonstrate initiative and have the ability to defend a decision based on specifications andprocedures. In addition the incumbent must have near vision correctable to at least 20/20 in one eye and 20/40 in the other eye, have no color blindexcellent color and depth discrimination, and be able to lift up to 50 lbs. The incumbent must be able to successfully pass the certification requiremfor product final container visual inspection. Work is performed in an office and a laboratory/manufacturing environment or warehouse. Exposure to biological fluids with potential exposure toinfectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment.Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precisecoordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35lbs.Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Colorperception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words andsentences. Performs tasks by following a set of written or oral instructions/procedures. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.** Learn more about Grifols (************************************** **Req ID:** 536840 **Type:** Regular Full-Time **Job Category:** TECHNICAL
    $50k-79k yearly est. 27d ago
  • Plant Maintenance Engineer

    Grifols Shared Services North America, Inc. 4.2company rating

    Clayton, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. **Responsibilities:** This role provides plant maintenance engineering support for 24x7 manufacturing operations at the Grifols Clayton site, Building 300 Purification. The Maintenance/Plant engineer has the primary responsibility for: + Ensure reliable production area operation in compliance with safety, regulatory, and production requirements while making independent decisions and resolving conflict within defined areas of responsibility. + Troubleshoot and identify root-cause mechanical system issues and process related problems so they can be corrected. + Become the mechanical, chemical, and process SME for the areas of responsibility within the building while serving as a consultant to management within that specified area. + Plans and organizes cross-functional activities. Partner with operations, maintenance and project engineering to identify and resolve issues (redesign, rebuild, repair, etc). + Actively pursue and manage process optimization technology, help improve operational efficiency, and implement continuous improvement projects. Advances technical project proposals through to completion. + Oversee outsourced vendor support. + Assist in training maintenance, instrumentation, and operations personnel. + Additional responsibilities include materials clearance, spare parts inventory, change controls, incident investigation, participating in safety reviews, specifications, leading projects during plant shutdowns and other common GMP engineering tasks. **Additional Skills Needed:** + Self-motivated and driven to succeed + Hands-on and a problem solver. Greater time in the field than at the desk. + Communicates effectively and promptly at all levels of the organization. + Strong theoretical and practical technical understanding with strong troubleshooting skills. + Works well with technical and non-technical personnel. + Solid technical writing and verbal communication skills. + Candidates with GMP and/or pharmaceutical industry experience are preferred **Requirements based on level:** **Engineer II:** + Bachelor's Degree in engineering or related field. + At least 2 years of experience. + Minimum of 2 years of experience working in a Biotech or Chemical company. GMP experience preferred **Engineer III:** + Bachelor's Degree in engineering or related field. Professional certifications and licenses as appropriate. + At least 4 years of experience. + Biotech, Chemical or Industrial experience preferred. **Engineer IV** + Bachelor's Degree in Engineering or related field. + Typically requires 5 years of related experience. + Biotech, Chemical or Industrial experience preferred. **Senior** **Engineer** + Bachelor's Degree in Engineering or related field. + Typically requires 6 years of related experience. + Biotech, Chemical or Industrial experience preferred. **Staff** **Engineer** + Bachelor's Degree in Engineering or related field. + Typically requires 7 years of related experience. + Biotech, Chemical or Industrial experience preferred. **Principal** **Engineer** + Bachelor's Degree in Engineering or related field. + Typically requires 8 years of related experience. + Biotech, Chemical or Industrial experience preferred. Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. Stands for 2-4 hours per day. Frequent movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Occasionally bends and twists neck and waist. Frequent foot movements. Color perception/discrimination, depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently performs routine tasks by following a set of written or oral instructions/procedures. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.** **Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton** Learn more about Grifols (************************************** **Req ID:** 534796 **Type:** Regular Full-Time **Job Category:** ENGINEERING / MAINTENANCE
    $71k-115k yearly est. 60d+ ago
  • HR Associate II

    Grifols Shared Services North America, Inc. 4.2company rating

    Clayton, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. **_Position Overview:_** Provides HR administrative support with the day to day operations in one or more of the following HR functions: Benefits, Business Partners, Communications, Compensation, Corporate Health, Employee Relations, Environmental Safety and Security, HRIS, Professional Development/Organizational Development, Staffing and/or Training-TPR. **_Job responsibilities include but are not limited to the following:_** ● Provides excellent customer service to divisional HR staff and employees. ● Prepares and maintains reports that are necessary to carry out the functions of the HR department. ● Organizes and maintains employee files. ● Enters and audits HR transactional data into a centralized HR database and ancillary HR systems. Ensures the information is accurate and adheres to corporate standards. ● Processes various forms related to documenting HR activities such as new-hire, change-of-status, performance evaluations, benefits, terminations, dependent eligibility audit, etc. ● Processes diverse and confidential information requiring extreme accuracy, independent judgment and discretion. ● Responds to questions from internal and external customers. ● Multi-tasks on a daily basis and prioritizes work. ● Schedules appointments, meetings, and interviews. Makes arrangements for travel. ● Performs data gathering and analysis. Performs basic recruiting activities including interviewing non-exempt positions. **_Skills/Qualifications/Education Requirements:_** (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions). + Associate's degree preferably in HR + Typically requires 4 years of HR experience + Excellent knowledge of HR policies, programs, operations and benefits + Excellent skills in Microsoft Office, Excel, and Word + Excellent verbal and written communication skills + Ability to multi-task in a fast-paced environment + Ability to communicate clearly and concisely over the telephone and to deal with difficult situations + Ability to manage multiple projects by prioritizing tasks and escalate issues in need of resolution + Ability to analyze and interpret data, identify errors and formulate solutions + Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level typically requires an Associate's degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor's degree. Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequently walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 30lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Interacts with others, relates sensitive information to diverse groups. \#LI-CB1 Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.** **Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton** Learn more about Grifols (************************************** **Req ID:** 537566 **Type:** Regular Full-Time **Job Category:** HUMAN RESOURCES
    $53k-83k yearly est. 11d ago
  • Phlebotomist

    Grifols Sa 4.2company rating

    Raleigh, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Phlebotomist - We Train You are a fit for us if you have: * Superior customer service standards * A High School diploma or GED * Ability to work a flexible schedule * An interest in making a difference in the world * Obtains required state licensures or certifications where applicable Phlebotomist Our ideal phlebotomist is patient, reliable, and really commits to keep our donors comfortable and happy. Primary Responsibilities: * Assist in determining the suitability of donors. * You establish rapport with donors to ensure overall customer happiness while ensuring donor confidentiality. * You respond to and assist with handling donor reactions. * Monitors donor and equipment to ensure health of donors and quality of product. * Sets up, disconnects, and operates the automated plasmapheresis machines. * Disconnects and disposes of all contaminated disposable equipment. We're Grifols, a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care. Occupational Demands Form # 74: Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while working in plasma freezer. Personal protective equipment required such as protective eyewear, garments, gloves and cold-gear. Work is performed standing for 6 to 8 hours per day. Bending and twisting neck and waist for 1-2 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement; may infrequently squat, crouch or sit on one's heels. May walk up to 6-8 hours per day. Light lifting of 15lbs. with a maximum lift of 50lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to comprehend and follow instructions to complete assigned tasks. must possess the ability to listen to and understand information and ideas presented through spoken words and sentences. must perform within the guidance of both oral or written instructions. Relates sensitive information to diverse groups. #biomatusa Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : NC-Raleigh:USRA2 - Raleigh NC-Garner Sta Bl-TPR
    $27k-36k yearly est. 1d ago
  • Clinical Research Associate 3

    Grifols Sa 4.2company rating

    Raleigh, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. The Clinical Research Associate assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols. Ensures coordination of an accelerated study start-up including pre-study visits, initiation, interim, and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study. Primary responsibilities include: * Tracking study specific tasks and progress of the trial. * Performing regulatory document review and approval for IP release. * Assisting in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings). * Conducting monitor training. * Performing monitoring/co-monitoring activities for site initiation visits, interim site monitoring, and closeout visits, in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies. * Understanding and implementing processes for distribution and tracking of SAE's, safety documentation, and pregnancies. Monitors compliance of these processes. * Collaborating with data management to resolve queries. * Facilitating investigator site payments, as applicable. * Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation. * Assisting in evaluation of vendor performance during conduct of the study. * Acquiring a basic knowledge of the therapeutic area and product. * Obtaining a complete understanding of all trial-related documents and operational procedures. * Gaining exposure/participates in CRF development, IVRS set-up, central lab set-up, and other vendor selection processes. * Maintaining clinical trial management system (CTMS) information pertaining to the study as applicable * Assisting with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation). * Reviewing and tracking study documents, including: project files both electronically and in the Trial Master File and Project Status Reports. * Preparing accurate and complete meeting minutes for various meetings. * Communicating and interacting with relevant study personnel, including: develops and maintains collaborative relationships to manage study issues and support milestone achievement; conveys project information; answers study questions in a timely manner while using discretion when to escalate to study manage; troubleshoots and follows up on study progress; and, reviews report data for completeness and accuracy. * Assists with effective and timely audit/inspection responses. For studies monitored in house by Grifols, additional responsibilities may include: * Identifies/screens/qualifies investigators through feasibility questionnaires and pre-study visits. * Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up. * Conducts/oversees completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine protocol and regulatory compliance. * Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity. * Reconciles clinical supplies and drug accountability records at study sites. * Identifies and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required. * Reviews, clarifies, and obtains, data changes via query resolutions with site personnel. * Prepares telephone contact reports, confirmation letters, site visit reports (PSV, SIV, IMV, and COV), and follow-up letters to accurately and completely document site status and activities. Additional responsibilities: Leads the activities of the CRA team to meet the study objectives. Identifies and addresses weaknesses in individual or team performance. Assists study manager in overall study management. Monitors and/or co-monitors as required with CRO and CRA staff to insure study integrity and compliance. Develops ICF templates and reviews study specific ICF(s). Participates in CRF development and completion. Reviews monitoring reports and QA reports from site visits. Manages clinical study set-up and follow-up study activities through tracking and review. Assists in the development of the clinical risk management plan. Develops, implements, and maintains monitoring plan for studies run internally. Coordinates and presents at investigator meetings, kick-off meetings, etc. Interacts as functional lead with data management, safety, regulatory personnel, and other functional groups. Leads team members in reviewing data listings in reviewing data listings and writing queries. Tracks and manages the distribution of study drug and clinical supplies. Contributes to development of site budget. Knowledge, Skills, and Abilities: Excellent knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs. Excellent knowledge of therapeutic area assigned. Excellent knowledge of ICH/GCP Guidelines and EDC process. Strong verbal and written communication skills. Ability to train others in using MS Office Suite, Impact, and EDC systems. Ability to meet deadlines, multitask, and prioritize based on study needs. Ability to make sound decisions based on available information. Ability to establish rapport with site personnel/ colleagues. Ability to work both in a team and independently. Ability to facilitate team meetings and teleconferences. Ability to present at internal study team meeting(s). Ability to train and mentor junior CRAs. Ability to seek new learning opportunities within and outside of the assigned project. Ability and willingness to travel. Requirements: * Associate's degree in a life science field required. Bachelor's degree in a life science field preferred. * Typically requires 5 years of experience in clinical research, including a minimum of 2 years field monitoring experience and 3 years in lead CRA role. * Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. Occupational Demands: Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : NC-RTP:[[cust_building]]
    $55k-90k yearly est. 40d ago
  • Electrical and Instrumentation Engineer - Staff/Principal

    Grifols Shared Services North America, Inc. 4.2company rating

    Clayton, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. **Primary Responsibilities for Role:** + Electrical and Instrumentation (E&I) Engineer for the pharmaceutical industry. + Will be required to manage assigned scope, cost, and schedule for responsible duties. + Will work in all phases of capital projects: planning, design, procurement, construction and start-up: + Design of low voltage power distribution and motor control. + Responsible for selection and sizing of instrumentation based on P&IDs. + Selects control system hardware based on site standards. + Prepares equipment specifications and bid packages. + Performs vendor & bid evaluations, progress monitoring and attendance of factory acceptance testing. + Responsible to field supervise contractors during construction to ensure safety, quality and schedule. + Responsible for providing contractors answers to questions that arise during construction. + Performs equipment start-up, develops and executes commissioning protocols and prepares turnover packages for the site. + Develops single lines, motor control schematics and loop sheets. + Sizes electrical components based on NFPA 70. + Modifies existing or develops new specifications to meet requirements of project scopes. + Coordinates with other disciplines throughout design, construction and startup. + Provides initial configuration settings for VFDs and Motor Starters. + Communication - Will be responsible for providing communications (verbal/written) within area of responsibility. + Use/demonstrate problem solving skills in order to best support and meet the needs within area of responsibility. + Promotes a collaborative and cooperative environment which embraces the ability to work effectively within teams. + Capable of adhering to Good Manufacturing Practices (GxP) - Compliance, Change Control, Quality Oversight, Validation. **Education and Experience requirements based on level:** **Staff Engineer Level:** + Minimum Education: Bachelor's Degree in Engineering or related field. + Professional registration and/or certifications as appropriate. + Minimum of 5 years of related experience. Experience in Biotech, Pharmaceutical or Chemical Industry preferred. **Principal Engineer Level:** + Minimum Education: Bachelor's Degree in Engineering or related field. + Professional registration and/or certifications as appropriate. + Minimum of 8 years of experience. Experience in Biotech, Pharmaceutical or Chemical Industry preferred. **Additional Requirements:** + PE license in NC preferred. + Will require occasional international travel (i.e. Spain, Canada) **Occupational Demands:** Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments, and gloves. Frequently sits for 4-6 hours per day. Stands for 2-4 hours per day. Frequent movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Occasionally bends and twists neck and waist. Frequent foot movements. Color perception/discrimination, depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently performs routine tasks by following a set of written or oral instructions/procedures. \#LI-VJ1 Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.** Learn more about Grifols (************************************** **Req ID:** 536220 **Type:** Regular Full-Time **Job Category:** ENGINEERING / MAINTENANCE
    $62k-85k yearly est. 53d ago
  • Customer Care Intern

    Grifols Sa 4.2company rating

    Raleigh, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Eligible applicants include: * Undergraduate students entering their junior or senior year, pursuing a degree in Business, Marketing, Psychology, Communications, Healthcare Management, or a related field (Sophomore entering Junior year OR Junior entering Senior year) OR * Senior going to Grad School (graduate students entering their first or second year of study) Grifols has been a leader in the healthcare industry since 1909 by creating innovative products and services based on the values of ethics, quality and responsibility. Grifols' activities focus on fulfilling the needs of its patients as well as healthcare professionals working in therapeutics, pharmacy, diagnostics and blood banking. For more than 100 years, Grifols has developed, manufactured and marketed products designed to improve human health. Grifols manufactures plasma derived biopharmaceutical products of proven efficacy, quality and safety. For more information, please visit our website:
    $26k-34k yearly est. 55d ago
  • Manufacturing Supervisor -NFB - (Night Shift) 1

    Grifols Shared Services North America, Inc. 4.2company rating

    Clayton, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. **Hours: 7am-7pm Day Shift** **Summary:** The Manufacturing Supervisor is responsible for a Manufacturing department's day to day operations to ensure the manufacture of products are within cGMP, safety regulations and policies and procedures. This is an entry level Supervisor role. Provides routine technical support and makes decisions within a well defined area of responsibility. **Primary Responsibilities for role (level specific responsibilities should be included in the chart below):** + Directs shift operations and ensures product integrity in accordance with the production schedule, cGMP, safety regulations and policies & procedures. + Maintains floor presence to minimize discrepancies and promote process compliance and accurate documentation. + Participates in process/product troubleshooting in order to correct/maintain desirable process parameter. + Acts as an initial point of contact for partner groups (i.e. Maintenance, Quality, Tech Doc Support, etc.) Research and address simple process deviations, documentation errors, etc. + Qualified to operate all equipment and lead processes to ensure the production schedule is met. + May recommend and with direction, implement measures to improve production methods, equipment performance, facility layout and quality of product. + Manage employees performance, coach and counsel for development. + Ensures required training for employee is achieved, effective and timely. + Makes decisions independently, but within a well-defined area. + Sought for counsel within field of expertise. This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and/or supervisors may assign other duties as needed. **Knowledge, Skills and Abilities** + Ability to communicate effectively at all levels of the organization. + Ability to lead teams and promote a positive and thriving team environment. + Ability to troubleshoot and provide sound solutions for complex process related matters. **Education:** + BA/BS degree + 2 years related experience. + Masters degree + 0 years **Experience:** + Previous leadership experience preferred. *Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. Work is performed in an office and/or a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to extreme cold below 32*, miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on production floor. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks. Often performs duties standing. Frequently bends and twists neck and waist. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Frequently drives to other facilities. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.** Learn more about Grifols (************************************** **Req ID:** 537176 **Type:** Regular Full-Time **Job Category:** MANUFACTURING
    $54k-77k yearly est. 4d ago
  • Plasma Process Data Analyst I/II

    Grifols Shared Services North America, Inc. 4.2company rating

    Clayton, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. **This is an hourly, entry-mid level position with some office exp needed.** **Plasma Process Data Analyst I** **Summary:** The Plasma Process Data Analyst maintains and prepares plasma yield and accountability reports; performs data entry using various software (i.e. Bioman, SAP, etc.) programs. He/she also prepares graphs, retrieves and verifies production data (yields and inventories); identifies discrepant data, yield trends, problem yields and provides analysis of yield data. **Primary responsibilities for role:** ● Maintains and generates a variety of reports (i.e. yield, trending, efficiency or KPIs, etc.) ● Enters data into database using various software (i.e. Bioman, SAP, Excel, etc.) ● Prepares graphs, collects and verifies production data (i.e. yield, inventory, etc.) ● Identifies discrepant data, yield trends, etc. ● Reviews process orders in order to determine what components (i.e. stoppers, etc.) are needed to meet production schedule ● Maintains inventory of production supplies (i.e. gowning or lab coats, operating and cleaning supplies, etc.) ● Prepare annual product reviews. ● May review Batch Production Records (BPRs) and SOPs for accuracy. ● Interacts with external vendors in order to secure components/supplies needed for the department. ● Other duties as assigned (i.e. projects, etc.) **Additional Responsibilities:** Alert Manufacturing if changes are made which impact BPRs. **Knowledge, Skills, and Abilities:** Requires the ability to analyze production data at various stages; May be required to interpret yield data; Must be able to work independently with a high degree of accuracy; May be able to detect inconsistencies, deviations and trends, etc. **Education:** High School diploma or equivalent. An associate's degree is preferred. An equivalent combination of education and experience may be considered. **Experience:** A minimum of two years of relevant experiences is required. Incumbent must have good written and verbal communication skills; the ability to analyze, proofread, and edit data; and possess excellent computer skills. **Equivalency:** Depending on the area of assignment, directly related experience or a combination of directly related education and exprience and/or competencies may be considered in place of the stated requirements. Example: If a job level typically requires an Associate's degree plus 2 years of experince , an equivalent could include 4 years of experience or a Bachelor's degree. **Plasma Process Data Analyst II** **Summary:** The Plasma Process Data Analyst II performs all duties of the Data Analyst I and performs a thorough forecast/analytic review of materials for the production and supplies needed in Manufacturing production to aid in financial audits, component inventory levels and on low/high yields that is utilized by Senior Management to make key decisions in these areas. **Primary responsibilities for role:** ● Perform all duties of a Plasma Processing Data Analyst I. ● Investigates and provides in-depth information to Sr. Management from financial reports on low/high yeilds. ● Analyzes inventory levels in SAP/quality incoming inspection and provides direction on priority of materials to be inspected /added to priority list. ● Provides memos to the investigation group to support incident investigations and to release quarantine material. ● Reconciles variances in SAP in order to be audit ready; department lead for finance audits. **Knowledge, Skills, and Abilities:** Requires the ability to analyze production data at various stages; May be required to interpret yield data; Must be able to work independently with a high degree of accuracy; May be able to detect inconsistencies, deviations and trends, etc. Strong SAP and/or excel experience. **Education:** High School diploma plus 4 years relevant experience. An associate's degree is preferred plus 2 years experience. **Equivalency:** Depending on the area of assignment, directly related experience or a combination of directly related education and exprience and/or competencies may be considered in place of the stated requirements. Example: If a job level typically requires an Associate's degree plus 2 years of experince , an equivalent could include 4 years of experience or a Bachelor's degree. Work is performed in an office and a laboratory/manufacturing environment or warehouse. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures. Recruiter - Kaleena Rozier Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.** Learn more about Grifols (************************************** **Req ID:** 535651 **Type:** Regular Full-Time **Job Category:** MANUFACTURING
    $60k-87k yearly est. 56d ago
  • Senior Associate Process Development Engineer I

    Grifols 4.2company rating

    Clayton, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Summary: As a key member of the team, the incumbent will provide comprehensive technical and scientific expertise in the development, scale-up, transfer, and support of production processes for plasma-derived proteins. The role focuses on advanced purification unit operations, including but not limited to precipitation, filtration, chromatography, tangential flow filtration, formulation, nanofiltration, and process troubleshooting. The successful candidate will leverage their scientific knowledge and hands-on experience to contribute to the advancement of innovative therapies. Primary Responsibilities: Support developmental projects, clinical manufacturing, and commercial manufacturing. Assist in the development and execution of action plans to support departmental goals. Prepare procedures and technical reports independently, including data analysis and interpretation. Report technical results in internal and cross-functional team settings. Develop solutions to complex technical problems within the area of expertise. Design scientifically rigorous experiments, including the interpretation of results. Ability to execute experiments independently and in a team setting. Conduct laboratory and clinical production work using standard processing and analytical equipment. Identify and collect data on critical process attributes and/or critical parameters for scaling. Support the start-up and commissioning of equipment and processes and the implementation of new raw materials on-site. Maintain laboratory and clinical manufacturing facilities in accordance with procedures. Knowledge Skills and Abilities: Possess the ability to set and meet deadlines, multitask, and prioritize personal objectives based on project needs. Exhibit the ability to adapt to a changing work environment. Have experience in technical writing and effective oral communication skills. Apply scientific or engineering principles to problem-solving. Be adept at working at various process scales, ranging from bench to pilot scale. Have knowledge and experience working in a GMP environment. Takes initiative to stay current in area of specialization (e.g., chromatography, filtration) and expand knowledge base. Be self-motivated and able to work effectively in a matrixed organization. Be proficient in using the MS Office Suite. Location: Clayton, NC Shift: Day Education and Experience: Senior Associate Process Development Engineer I Level: Bachelor's degree in a relevant science or engineering field with 4+ years of relevant work experience, Associate's degree with 6+ years of experience, or an equivalent combination of education and experience. Occupational Demands for Engineer: Work is performed in a clinical and/or laboratory environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to chemicals. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits and bends neck for 4-6 hours per day. May stand and twist neck for 2-4 hours per day. Occasionally walks, bends and twists waist and squats. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Moderate lifting of 15-30lbs. with a maximum lift of 35 lbs. May reach above and below shoulder height. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently works with diverse groups to obtain consensus on complex issues. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton Learn more about Grifols
    $86k-111k yearly est. 60d+ ago
  • Director, R&D Regulatory Strategy

    Grifols Sa 4.2company rating

    Clayton, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Summary: Leads the R&D Regulatory Strategy group for assigned products in managing regulatory programs in support of R&D activities. Oversees and/or participates in the development and implementation of worldwide regulatory programs for new product or new indication development, and leads interactions with regulatory authorities to expedite approvals. Coordinates department activities with related RA functions to assure efficient and consistent execution of department functions. Represents the department at senior-level, cross functional teams, applying advanced knowledge of regulations and interpretation of technical guidelines to assure execution of regulatory strategies and adherence to regulatory requirements. Oversees staff to ensure the efficient operations of the function. Primary Responsibilities: * As Global Regulatory Lead, develops and oversees worldwide regulatory strategies for projects and issues affecting new products or new indication development. * Leads interactions and negotiates with global regulatory authorities regarding programs and initiatives that significantly impact the business. * Serves as a resource to other departments inside and outside of R&D on regulatory-related product development issues. * Guides, directs, and leads staff, and develops department goals in accordance with business priorities. Responsible for training, reviews and development of department members. * Advises Senior Management on regulatory aspects of product development and/or lifecycle management. Identifies business implications of complex regulatory and clinical issues, develops risk mitigation strategies and communicates in a manner that facilitates decision making. * Serves as Grifols regulatory liaison in collaborative projects with other companies * Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory requirements. * Manages department resources and budget to meet R&D goals * Utilizes scientific training when interfacing with Senior Management of technical areas to guide the scope of experimentation and the selection of data needed to support regulatory submissions Knowledge, Skills, & Abilities: Comprehensive knowledge and understanding of FDA and global regulatory requirements for the biotechnology and pharmaceutical industry. Deep experience in clinical development, trial design statistical principles is essential. Excellent oral and written communication skills. Strong critical thinking and problem solving skills. Excellent and demonstrated project management skills. Ability to negotiate and influence regulatory officials. Ability to work cross-functionally to effectively implement and oversee R&D regulatory programs. Ability to evaluate complex issues, develop a plan, and meet deadlines to ensure compliance, as well as business timelines to accomplish company objectives. Ability to work within a global team framework and multi-cultural environment. Minimum Requirements: Requires Ph.D., Pharm. D.,M.D. or equivalent and, 8 years direct experience in Medical Research, Clinical, Regulatory Affairs or other critical areas within the pharmaceutical industry. Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. Occupational Demands: Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Frequently walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations and frequently travels within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Pay Scale: The estimated pay scale for the Director, R&D Regulatory Strategy role based in the United States (non-California), is $175,000.00 - $240,000.00 per year. Additionally, the position is eligible to participate in 30% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, 9 paid Holidays per year, up to 5% 401(K) match, and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : NC-Clayton || NORTH AMERICA : USA : AL-Birmingham || NORTH AMERICA : USA : AL-Decatur || NORTH AMERICA : USA : AL-Dothan || NORTH AMERICA : USA : AL-Hueytown || NORTH AMERICA : USA : AL-Huntsville || NORTH AMERICA : USA : AL-Mobile || NORTH AMERICA : USA : AL-Montgomery || NORTH AMERICA : USA : AL-Opelika || NORTH AMERICA : USA : AL-Phenix City || NORTH AMERICA : USA : AL-Tuscaloosa || NORTH AMERICA : USA : CT-Hartford || NORTH AMERICA : USA : CT-New Haven || NORTH AMERICA : USA : CT-Stamford || NORTH AMERICA : USA : DC-Washington || NORTH AMERICA : USA : DE-Newark || NORTH AMERICA : USA : DE-Wilmington || NORTH AMERICA : USA : FL-Altamonte Springs || NORTH AMERICA : USA : FL-Boca Raton || NORTH AMERICA : USA : FL-Clearwater || NORTH AMERICA : USA : FL-DeLand || NORTH AMERICA : USA : FL-Ft Myers || NORTH AMERICA : USA : FL-Ft Walton Bch || NORTH AMERICA : USA : FL-Ft. Lauderdale || NORTH AMERICA : USA : FL-Gainesville || NORTH AMERICA : USA : FL-Hollywood || NORTH AMERICA : USA : FL-Jacksonville || NORTH AMERICA : USA : FL-Kissimmee || NORTH AMERICA : USA : FL-Melbourne || NORTH AMERICA : USA : FL-Miami || NORTH AMERICA : USA : FL-Miami || NORTH AMERICA : USA : FL-Ocala || NORTH AMERICA : USA : FL-Orlando || NORTH AMERICA : USA : FL-Panama City || NORTH AMERICA : USA : FL-Pensacola || NORTH AMERICA : USA : FL-Royal Palm Beach || NORTH AMERICA : USA : FL-Sarasota || NORTH AMERICA : USA : FL-St. Petersburg || NORTH AMERICA : USA : FL-Tallahassee || NORTH AMERICA : USA : FL-Winter Haven || NORTH AMERICA : USA : GA-Albany || NORTH AMERICA : USA : GA-Athens || NORTH AMERICA : USA : GA-Atlanta || NORTH AMERICA : USA : GA-Augusta || NORTH AMERICA : USA : GA-Columbus || NORTH AMERICA : USA : GA-Hinesville || NORTH AMERICA : USA : GA-Macon || NORTH AMERICA : USA : GA-Marietta || NORTH AMERICA : USA : GA-Norcross || NORTH AMERICA : USA : GA-Savannah || NORTH AMERICA : USA : GA-Statesboro || NORTH AMERICA : USA : GA-Stonecrest || NORTH AMERICA : USA : GA-Valdosta || NORTH AMERICA : USA : IL-Bloomington || NORTH AMERICA : USA : IL-Carbondale || NORTH AMERICA : USA : IL-Champaign || NORTH AMERICA : USA : IL-Chicago || NORTH AMERICA : USA : IL-Elgin || NORTH AMERICA : USA : IL-Joliet || NORTH AMERICA : USA : IL-Peoria || NORTH AMERICA : USA : IL-Rockford || NORTH AMERICA : USA : IL-Waukegan || NORTH AMERICA : USA : IL-Wood River || NORTH AMERICA : USA : KS-Kansas City || NORTH AMERICA : USA : KS-Olathe || NORTH AMERICA : USA : KS-Topeka || NORTH AMERICA : USA : KS-Wichita || NORTH AMERICA : USA : KY-Bowling Green || NORTH AMERICA : USA : KY-Lexington || NORTH AMERICA : USA : KY-Louisville || NORTH AMERICA : USA : KY-Owensboro || NORTH AMERICA : USA : KY-Paducah || NORTH AMERICA : USA : LA-Alexandria || NORTH AMERICA : USA : LA-Baton Rouge || NORTH AMERICA : USA : LA-Houma || NORTH AMERICA : USA : LA-Lafayette || NORTH AMERICA : USA : LA-Lake Charles || NORTH AMERICA : USA : LA-Monroe || NORTH AMERICA : USA : LA-New Orleans || NORTH AMERICA : USA : LA-Ruston || NORTH AMERICA : USA : LA-Shreveport || NORTH AMERICA : USA : MA-Boston || NORTH AMERICA : USA : MA-Fall River || NORTH AMERICA : USA : MA-Medford || NORTH AMERICA : USA : MA-Worcester || NORTH AMERICA : USA : MD-Baltimore || NORTH AMERICA : USA : MD-Frederick || NORTH AMERICA : USA : ME-Lewiston || NORTH AMERICA : USA : ME-Maine || NORTH AMERICA : USA : MI-Battle Creek || NORTH AMERICA : USA : MI-Benton Harbor || NORTH AMERICA : USA : MI-Detroit || NORTH AMERICA : USA : MI-Farmington Hills || NORTH AMERICA : USA : MI-Flint || NORTH AMERICA : USA : MI-Inkster || NORTH AMERICA : USA : MI-Kalamazoo || NORTH AMERICA : USA : MI-Lansing || NORTH AMERICA : USA : MI-Muskegon || NORTH AMERICA : USA : MI-Port Huron || NORTH AMERICA : USA : MI-Saginaw || NORTH AMERICA : USA : MN-Fridley || NORTH AMERICA : USA : MN-Minneapolis || NORTH AMERICA : USA : MN-Moorhead || NORTH AMERICA : USA : MN-St. Paul || NORTH AMERICA : USA : MN-West St Paul || NORTH AMERICA : USA : MO-Cape Girardeau || NORTH AMERICA : USA : MO-Columbia || NORTH AMERICA : USA : MO-Independence || NORTH AMERICA : USA : MO-Kansas City || NORTH AMERICA : USA : MO-Springfield || NORTH AMERICA : USA : MO-St Joseph || NORTH AMERICA : USA : MO-St. Louis || NORTH AMERICA : USA : NC-Asheville || NORTH AMERICA : USA : NC-Atlantic Beach || NORTH AMERICA : USA : NC-Benson || NORTH AMERICA : USA : NC-Charlotte || NORTH AMERICA : USA : NC-Durham || NORTH AMERICA : USA : NC-Fayetteville || NORTH AMERICA : USA : NC-Gastonia || NORTH AMERICA : USA : NC-Goldsboro || NORTH AMERICA : USA : NC-Greenville || NORTH AMERICA : USA : NC-Jacksonville || NORTH AMERICA : USA : NC-Kannapolis || NORTH AMERICA : USA : NC-North Carolina || NORTH AMERICA : USA : NC-RTP || NORTH AMERICA : USA : NC-Raleigh || NORTH AMERICA : USA : NC-Wilmington || NORTH AMERICA : USA : NC-Winston Salem || NORTH AMERICA : USA : ND-Bismarck || NORTH AMERICA : USA : ND-Minot || NORTH AMERICA : USA : NE-Kearney || NORTH AMERICA : USA : NE-Lincoln || NORTH AMERICA : USA : NE-Omaha || NORTH AMERICA : USA : NJ-Atlantic City || NORTH AMERICA : USA : NJ-Camden || NORTH AMERICA : USA : NJ-Cherry Hill || NORTH AMERICA : USA : NJ-Freehold || NORTH AMERICA : USA : NJ-New Brunswick || NORTH AMERICA : USA : NJ-Newark || NORTH AMERICA : USA : NJ-Toms River || NORTH AMERICA : USA : NJ-Trenton || NORTH AMERICA : USA : NY-Albany || NORTH AMERICA : USA : NY-Binghamton || NORTH AMERICA : USA : NY-Buffalo || NORTH AMERICA : USA : NY-Melville || NORTH AMERICA : USA : NY-Rochester || NORTH AMERICA : USA : NY-Syracuse || NORTH AMERICA : USA : OH-Akron || NORTH AMERICA : USA : OH-Bowling Green || NORTH AMERICA : USA : OH-Canton || NORTH AMERICA : USA : OH-Cincinnati || NORTH AMERICA : USA : OH-Cleveland || NORTH AMERICA : USA : OH-Columbus || NORTH AMERICA : USA : OH-Dayton || NORTH AMERICA : USA : OH-Lorain || NORTH AMERICA : USA : OH-Mansfield || NORTH AMERICA : USA : OH-Newark || NORTH AMERICA : USA : OH-Shaker Heights || NORTH AMERICA : USA : OH-Toledo || NORTH AMERICA : USA : OH-Whitehall || NORTH AMERICA : USA : OH-Youngstown || NORTH AMERICA : USA : OH-Zanesville || NORTH AMERICA : USA : PA-Allentown || NORTH AMERICA : USA : PA-Dickson City || NORTH AMERICA : USA : PA-Erie || NORTH AMERICA : USA : PA-Fairless Hills || NORTH AMERICA : USA : PA-Harrisburg || NORTH AMERICA : USA : PA-Lancaster || NORTH AMERICA : USA : PA-Lehigh Valley || NORTH AMERICA : USA : PA-McKeesport || NORTH AMERICA : USA : PA-Penn Hills || NORTH AMERICA : USA : PA-Philadelphia || NORTH AMERICA : USA : PA-Pittsburgh || NORTH AMERICA : USA : PA-Reading || NORTH AMERICA : USA : PA-Wilkes-barre || NORTH AMERICA : USA : PA-Williamsport || NORTH AMERICA : USA : RI-Cranston || NORTH AMERICA : USA : SC-Charleston || NORTH AMERICA : USA : SC-Clemson || NORTH AMERICA : USA : SC-Columbia || NORTH AMERICA : USA : SC-Greenville || NORTH AMERICA : USA : SC-Greenwood || NORTH AMERICA : USA : SC-Myrtle Beach || NORTH AMERICA : USA : SC-Rock Hill || NORTH AMERICA : USA : SC-Sumter || NORTH AMERICA : USA : TN-Chattanooga || NORTH AMERICA : USA : TN-Clarksville || NORTH AMERICA : USA : TN-Cookeville || NORTH AMERICA : USA : TN-Jackson || NORTH AMERICA : USA : TN-Johnson City || NORTH AMERICA : USA : TN-Kingsport || NORTH AMERICA : USA : TN-Knoxville || NORTH AMERICA : USA : TN-Memphis || NORTH AMERICA : USA : TN-Murfreesboro || NORTH AMERICA : USA : TN-Nashville || NORTH AMERICA : USA : TX-Abilene || NORTH AMERICA : USA : TX-Amarillo || NORTH AMERICA : USA : TX-Arlington || NORTH AMERICA : USA : TX-Austin || NORTH AMERICA : USA : TX-Beaumont || NORTH AMERICA : USA : TX-Brownsville || NORTH AMERICA : USA : TX-Bryan || NORTH AMERICA : USA : TX-Carrollton || NORTH AMERICA : USA : TX-Channelview || NORTH AMERICA : USA : TX-College Station || NORTH AMERICA : USA : TX-Corpus Christi || NORTH AMERICA : USA : TX-Dallas || NORTH AMERICA : USA : TX-Del Rio || NORTH AMERICA : USA : TX-Eagle Pass || NORTH AMERICA : USA : TX-Edinburg || NORTH AMERICA : USA : TX-El Paso || NORTH AMERICA : USA : TX-FT Worth || NORTH AMERICA : USA : TX-Fort Worth || NORTH AMERICA : USA : TX-Ft. Worth || NORTH AMERICA : USA : TX-Garland || NORTH AMERICA : USA : TX-Houston || NORTH AMERICA : USA : TX-Humble || NORTH AMERICA : USA : TX-Killeen || NORTH AMERICA : USA : TX-Lancaster || NORTH AMERICA : USA : TX-Laredo || NORTH AMERICA : USA : TX-Leon Valley || NORTH AMERICA : USA : TX-Longview || NORTH AMERICA : USA : TX-Lubbock || NORTH AMERICA : USA : TX-Lufkin || NORTH AMERICA : USA : TX-McAllen || NORTH AMERICA : USA : TX-Mission || NORTH AMERICA : USA : TX-Nacogdoches || NORTH AMERICA : USA : TX-Odessa || NORTH AMERICA : USA : TX-PA-Port Arthur || NORTH AMERICA : USA : TX-San Angelo || NORTH AMERICA : USA : TX-San Antonio || NORTH AMERICA : USA : TX-San Marcos || NORTH AMERICA : USA : TX-Temple || NORTH AMERICA : USA : TX-Texarkana || NORTH AMERICA : USA : TX-Victoria || NORTH AMERICA : USA : TX-Waco || NORTH AMERICA : USA : TX-While Settlement || NORTH AMERICA : USA : TX-Wichita Falls || NORTH AMERICA : USA : VA-Arlington || NORTH AMERICA : USA : VA-Bristol || NORTH AMERICA : USA : VA-Charlottesville || NORTH AMERICA : USA : VA-Chesapeake || NORTH AMERICA : USA : VA-Danville || NORTH AMERICA : USA : VA-Danville || NORTH AMERICA : USA : VA-FUTURE || NORTH AMERICA : USA : VA-Hampton || NORTH AMERICA : USA : VA-Harrisonburg || NORTH AMERICA : USA : VA-Newport News || NORTH AMERICA : USA : VA-Norfolk || NORTH AMERICA : USA : VA-Portsmouth || NORTH AMERICA : USA : VA-Richmond || NORTH AMERICA : USA : VA-Roanoke || NORTH AMERICA : USA : VA-Winchester || NORTH AMERICA : USA : VT-Vermont || NORTH AMERICA : USA : WI - Green Bay || NORTH AMERICA : USA : WI-Kenosha || NORTH AMERICA : USA : WI-Madison || NORTH AMERICA : USA : WI-Menasha || NORTH AMERICA : USA : WI-Milwaukee:USNC0001 - RTP NC-Headquarters
    $175k-240k yearly 26d ago
  • Sr. Regulatory Affairs Specialist II/Manager

    Grifols Sa 4.2company rating

    Clayton, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Summary: Implement worldwide regulatory product registration strategies, prepare complex registration dossiers, establish and maintain tracking of product registrations to determine what products can be shipped to intended markets in accordance with business plan with a specific focus on labeling, labeling requirements, and implementation. Coordinate and submit all regulatory documentation for establishment of new / changed local market authorization holders and distributors. Primary Responsibilities: * Act as Regulatory Affairs authority for key product registrations with a main focus in labeling and labeling related activities. * Analyze and determine worldwide product registration requirements for specific assigned products and regions. Implement worldwide regulatory registration strategy, communicate and negotiate with local market authorization holders/ distributors / regulatory authorities the information required and prepare regulatory submissions to be used worldwide for all marketed products. * Prepare complex registration dossiers, local application forms; negotiate documentation required for worldwide markets which may include product custom clearance documentation and coordinate with International Customer Service, Quality and Commercial preparation of required documentation in accordance with local requirements. * Prepare responses to regulatory agency inquiries. * Coordinate with local authorities and Quality standards and controls required for product registration testing. * Represent the regulatory function in communication with outside companies, customers and regulatory authorities. Responsibilities may include preparation and presentation (if required) to regulatory authorities. (e.g. labeling specific projects). * Represent the regulatory function on project teams as related to worldwide product registrations. Provide information that is presented to, for example, the Peer Review Committee, the Site Leadership Team and the Quality Management Review to enable informed decisions. * Collaborate with all disciplines to assure appropriate testing and documentation are generated for regulatory submissions and routine import documentation. Prepare personnel from affiliates or third parties for meetings with regulatory authorities. * Coordinate and interact with domestic and international regulatory counterparts to obtain input regarding regulatory considerations and decisions to formulate regulatory strategy for changes to products/facilities/equipment with an impact on product labeling. * Request and obtain all required FDA export documentation required for registration and routine product shipments. * Evaluate impact of new labeling regulatory requirements as well as evaluate changes to existing product labeling on assigned projects and products and inform other departments as necessary. * Maintain worldwide product registration status and distribute routine updates to commercial, sales and Quality to determine where registered products can be marketed. * Mentor and support the professional development of staff. * Perform other duties as required. Knowledge, Skills, and Abilities: * Ability to prioritize and initiate contacts essential to labeling submission preparation. * Ability to work independently and initiate contacts essential to create labeling components for submission preparation while ensure technical information is accurate. * Knowledge of product and labeling history to maintain consistency within a product line and within the product portfolio labeling. * Ability to clearly communicate verbally and in writing with internal and external contacts that may include industry representatives, affiliates, third parties and regulatory authorities in various countries. * Ability to work with management of other Grifols departments to achieve common business goals as well as regulatory objectives. * Ability to review a document, including labeling, in detail to ensure accuracy based on regulatory requirements, and to ensure the use of the appropriate forms, format, content, and authorized signatures. * Ability to effectively use Microsoft Office (particularly Word and Excel) to create, edit, and format documents * Ability to work with other computer systems for filing supplements and reports. * Ability to interpret and effectively communicate regulatory requirements internally as well as to distributors/affiliates with a specific focus in labeling. * Ability to successfully interact with external contacts which may include worldwide distributors / Grifols affiliates / regulatory agencies through professional, articulate, and courteous conversations and clear, concise written communications. * Ability to meet statutory deadlines to ensure compliance, as well as business timelines to accomplish company objectives. Preferred Background: * Advanced degree with clinical experience * Experience working on global labeling initiatives and submissions * Familiarity with electronic labeling systems and regulatory publishing tools * Demonstrated leadership in cross-functional team settings Minimum Requirements: Sr. Specialist II * Bachelor's degree in relevant discipline, or equivalent work experience industry regulatory experience. * Minimum 5 years of related technical and/or regulatory experience in pharmaceutical industry or an equivalent combination of education and experience. * Experience with biological products related to but not limited to facilities, validation, environmental monitoring, cGMP manufacturing, QA/QC for biological products, compliance and/or regulatory is required. * Excellent written and verbal communication skills. * Knowledge of applicable laws and regulations Manager * Bachelor's degree in relevant discipline, or equivalent work experience industry regulatory experience. * 6 to 7 years related technical and/or regulatory experience in pharmaceutical industry, or an equivalent combination of education and experience. * Extensive knowledge of applicable worldwide regulatory product registrations laws and regulations. * Excellent verbal and written communication skills Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton
    $49k-69k yearly est. 12d ago
  • Plasma Classification Certified Inspector

    Grifols Shared Services North America, Inc. 4.2company rating

    Clayton, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. **Plasma Classification Certified Inspector** **1st Shift - Monday - Friday 5:00am - 1:30pm** Position requires scanning and removal of unsuitable plasma units utilizing the Plasma Management System (SGP). A visual inspection of plasma units is also performed, removing any units which are unacceptable (e.g. damaged, broken port/tube, RBC, or backup sample rejections). Employee must be able to perform secondary verifications and Perform end of PU line clearances. **Responsibilities** + Scanning of plasma units assigned to a PU utilizing a barcode reader. + Scanning of archive samples assigned to a SA utilizing a barcode reader. + Transferring units to a Sub-shipment during the PU process. + Entering "Statistics" during the PU process. + Sub-shipment verification at the end of the PU process. + "Blocking" of units which do not meet customer requirements. + Responsible for various rejections found during visual inspection. + Removal of unsuitable plasma units marked for removal in SGP during the PU process. + Able to maintain record accountability. + Able to perform job duties with minimum supervision. + Ability to follow written procedures. + Monitoring plasma time out of freezer + Department housekeeping and safety practices + Processing of unsuitable plasma units during any step of the plasma process. + Transfer of unsuitable plasma units (status 100) to correct reject inventory + Transferring units between PU/LOT to a PU. + Ability to consistently meet department average throughput. + Knowledge of SGP Status codes and Disposition Codes. + Knowledge of labeling Requirements. + Scanning of case/units to a 3rd party sale utilizing Disposition Module. + Scanning of case/units to a MDO process utilizing Disposition Module. + Completing the partial PU cases between PU's. + Line Clearance at the end of a Plasma Process. **Requirements** + High School diploma or equivalent. + Two years' experience in Manufacturing, Pharmaceutical or other FDA licensed Industry is desirable. + Knowledge of cGMPs and Industry Standards. + Ability to follow "Standard Operating Procedures". + Possess good verbal and written communication skills. + Possess basic math skills (addition, subtraction, division, multiplication). + Basic Computer skills. **Occupational Demands** Work is performed in a manufacturing environment with rotating shifts. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to chemicals, electrical manufacturing equipment, hand tools and moving machinery. Exposure to high levels of noise and to extreme cold below 32*. Occasional entry into confined spaces requiring kneeling and squatting. Operates forklifts, tractors and power equipment. Personal protective equipment required such as protective eyewear, safety shoes, gloves and garments. Work is performed standing and walking for 6-8 hours per day. Bending and twisting neck and waist for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement. Frequent moderate lifting and carrying of 15-44lbs. Frequent heavy lifting and carrying of 45lbs. with a maximum lift of 50lbs. Occasionally reaches above and below shoulder height. Hearing acuity essential. Color perception/discrimination, depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently performs simple and routine tasks that vary little each day by following a set of written or oral instructions/procedures. **We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years - we're growing, and you can grow with us!** \#BiomatUSA Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.** **Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton** Learn more about Grifols (************************************** **Req ID:** 537774 **Type:** Regular Full-Time **Job Category:** MANUFACTURING
    $35k-62k yearly est. 4d ago

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