Company Description

The work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

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 works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

If you’re looking for a rewarding career, a place to call home, apply with us today!  

Job Description

POSITION SUMMARY:

The Manufacturing QA Associate contributes to Quality Assurance on the floor activities related to drug substance manufacturing. The colleague uses fundamental knowledge of GMP, and established procedures methodologies to provide quality oversight of manufacturing documentation, housekeeping, and overall GMP compliance.  The Associate ensures the site performs in a state of compliance by contributing to Quality oversight activities while fostering an empowered culture of quality across all functions.

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 ProceduresWork independently and with minimal supervisionProvides excellent communicationPerform 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

BASIC QUALIFICATIONS

A Bachelor's degree in a relevant discipline (e.g., microbiology, chemistry, biological sciences, bioengineering, etc.). preferred.3-5 years of experience in Quality Assurance in GMP facilities, drug substance preferred3-5 years of experience with batch record review, housekeeping monitoring, GMP document review and/or creation.3-5 years of experience reviewing deviation reports, change controls, CAPA, and analytical data.3-5 years of experience with Data IntegrityKnowledge of and experience in GMP, following applicable regulations, or willingness to become GMP proficient.

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.

Excellent full-time benefits including comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysEligibility for potential yearly Bonus & Merit-Based Pay Increases

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.