Pharmaceutical QA Senior Specialist - Group Leader

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 specialised 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 decentralised 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.

This position provides Quality Assurance oversight for Quality Control (QC). Provide QA (Quality Assurance) review and approval of Quality method validation / QC equipment qualification, QC protocol, reports, QC process control document, new and existing procedures, and Quality Control deviation / investigations. Supports process improvements implementation. This role is in Sanford, NC.

POSITION RESPONSIBILITIES :

• Perform QA technical review for assigned areas such as Validation documents, Method transfer Protocol amongst others.
• Provide final QA approval on simple change control, effectiveness check, CAPA implementations, compendial assessments, and other documents associated with the business unit.
• May also review and approve documents such as Deviation, complaints investigations, Laboratory investigations (OOS / OOT / OOE), and other Quality Events / Lab Events, Electronic build of Master Batch or any electronic record when needed, and all associated to compendial changes.
• Capable to Make quality decisions in real time according to regulations and procedures.
• Ability to work collaboratively with internal partners to resolve technical issues.
• Willing to perform other duties as assigned and take ownership to support the implementation of activities needed for the start-up.
• Bachelor's or Master's Degree in relatable field (Microbiology, Chemistry, Pharmaceuticals, etc.)

Bachelor's degree and 6-8 years of experience

Relevant experience includes :

Manufacturing, laboratory, quality, technical or engineering experience within biotech of the pharmaceutical industry

Positions are full-time, Monday - Friday 8am - 5 pm with overtime as needed. Candidates currently living within a commutable distance of Sanford, NC are encouraged to apply.

What we offer :

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.