Eurofins Viracor BioPharma Services
Pharmaceutical Manufacturing QA Associate
Eurofins Viracor BioPharma Services, Sanford, North Carolina, United States, 27330
Pharmaceutical Manufacturing QA Associate
Company Description
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience contract research organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences, and in the support of clinical studies, as well as having an emerging global presence in contract development and manufacturing organisations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in‑vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.
Job Description Core Job Duties
Performs duties with the guidance of Senior Associates
Execute real‑time review of batch documentation and other manufacturing documentation, analyzing for errors, corrections, and compliance
Support Transfer Master Cell Banks to Manufacturing
Perform housekeeping and GMP walkthroughs of facility
Initiate deviations in real time and assist in investigations
Work in cross‑functional teams to meet and exceed timelines
Execute or review room and line clearances
Makes quality decisions in real time according to regulations ICH Q7 and 21 CFR 211 and internal procedures
Additional Responsibilities
Support or initiate analytical test results initial investigation on the floor
Review and may approve manufacturing analytical testing on the floor
Use analytical skills to help ensure shop floor compliance with internal standards and procedures
Draft and review Standard Operating Procedures
Perform other duties as assigned and take ownership to support the implementation of activities needed, including but not limited to facility start‑up and continuous operations
Qualifications
A Bachelor’s or Master’s degree in a relevant discipline (e.g., microbiology, chemistry, biological sciences, bioengineering, etc.).
• Bachelor’s degree + 2‑4 years of relevant experience
• Master’s degree + up to 2 years of relevant experience
Relevant experience includes:
Quality Assurance in GMP facilities, drug substance preferred
Batch record review, housekeeping monitoring, GMP document review and/or creation
Reviewing deviation reports, change controls, CAPA, and analytical data
Experience with Data Integrity
Knowledge of and experience in GMP, following applicable regulations, or willingness to become GMP proficient
Authorization to work in the United States indefinitely without restrictions or sponsorship
Position Details Full‑time, Monday‑Friday 8:00 am – 5:00 pm. Candidates currently living within a commutable distance of Sanford, NC are encouraged to apply.
Benefits
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
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Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience contract research organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences, and in the support of clinical studies, as well as having an emerging global presence in contract development and manufacturing organisations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in‑vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.
Job Description Core Job Duties
Performs duties with the guidance of Senior Associates
Execute real‑time review of batch documentation and other manufacturing documentation, analyzing for errors, corrections, and compliance
Support Transfer Master Cell Banks to Manufacturing
Perform housekeeping and GMP walkthroughs of facility
Initiate deviations in real time and assist in investigations
Work in cross‑functional teams to meet and exceed timelines
Execute or review room and line clearances
Makes quality decisions in real time according to regulations ICH Q7 and 21 CFR 211 and internal procedures
Additional Responsibilities
Support or initiate analytical test results initial investigation on the floor
Review and may approve manufacturing analytical testing on the floor
Use analytical skills to help ensure shop floor compliance with internal standards and procedures
Draft and review Standard Operating Procedures
Perform other duties as assigned and take ownership to support the implementation of activities needed, including but not limited to facility start‑up and continuous operations
Qualifications
A Bachelor’s or Master’s degree in a relevant discipline (e.g., microbiology, chemistry, biological sciences, bioengineering, etc.).
• Bachelor’s degree + 2‑4 years of relevant experience
• Master’s degree + up to 2 years of relevant experience
Relevant experience includes:
Quality Assurance in GMP facilities, drug substance preferred
Batch record review, housekeeping monitoring, GMP document review and/or creation
Reviewing deviation reports, change controls, CAPA, and analytical data
Experience with Data Integrity
Knowledge of and experience in GMP, following applicable regulations, or willingness to become GMP proficient
Authorization to work in the United States indefinitely without restrictions or sponsorship
Position Details Full‑time, Monday‑Friday 8:00 am – 5:00 pm. Candidates currently living within a commutable distance of Sanford, NC are encouraged to apply.
Benefits
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
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