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 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.

Job Description

CORE JOB DUTIES:

Performs duties with the guidance of Sr. AssociatesExecute real time review of batch documentation and other manufacturing documentation analyzing for errors, corrections, and complianceSupport Transfer Master Cell Banks to ManufacturingPerform housekeeping and GMP walkthroughs of facilityInitiate deviations in real time and assists in investigationsWork in cross functional teams to meet and exceed timelinesExecute or review room and line clearancesMakes quality decision in real time according to regulations ICH Q7 and 21CFR211 and internal procedures

ADDITIONAL RESPONSIBILITIES

Support/initiate analytical test results initial investigation on the floorReviews and may approve manufacturing analytical testing on the floorUses analytical skills to help ensure shop floor compliance to internal standards and proceduresDraft and review Standard Operating ProceduresPerform 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.

QualificationsA 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 preferredBatch record review, housekeeping monitoring, GMP document review and/or creation.Reviewing deviation reports, change controls, CAPA, and analytical data.Experience with Data IntegrityKnowledge 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

Additional Information

Position is full-time, Monday - Friday 8:00am - 5:00pm.  Candidates currently living within a commutable distance of Sanford, NC are encouraged to apply.

Excellent full time benefits including comprehensive medical coverage, dental, and vision options.

Life and disability insurance401(k) with company matchPaid vacation and holidays

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