What are the responsibilities and job description for the Quality Assurance Supervisor position at Eurofins USA BioPharma Services?
Job Description
Job Description
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 Organization 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 Organizations. 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.
Job Description
- Supports administrative function by :
o acting as the Deputy Quality Assurance Manager in their absence
o responsible for assigning Quality Assurance group tasks as workload requires
o responsible for supervising training of Quality Assurance group on assigned training requirement
o responsible for internal QA department documents
o primary contact for the PO system for the QA group
o monitoring Analytical Subcontractor compliance
o writing, reviewing, and approving Events, CAPA, OOS / OOT and Change Control
o managing investigations
o writing, reviewing, and conducting Quality System, cGMP, and GLP training
o participating in data analysis and reporting
o serving as QA trainer, as needed
o supporting sister sites(s) as required
o data reporting
o document control
o equipment control
o performing Internal audits per Standard Operating Procedure
o supporting and hosting client and regulatory audits
o conducting external audits
o reviewing and approving Stability Protocols
o reviewing Stability Chamber Pull Schedules
o reviewing and approving Stability Chamber mapping
o monitoring and following up Stability Chamber excursions
o executing and reviewing batch records
o quality assurance inspection and release of cGMP materials
o reviewing, creating, and approving Master Batch Records
o reviewing, creating, and approving Certificates of Compliance
o conducting cGMP vendor qualification
Qualifications
Additional Information
Position is full-time, Monday - Friday 8am - 5pm . Candidates currently living within a commutable distance of Cary, NC are encouraged to apply.
Eurofins USA BioPharma Services is a M / F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
