Manufacturing QA Associate
4 weeks ago
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 DescriptionPOSITION 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. 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 assists in investigations
- Work in cross functional teams to meet and exceed timelines
- Execute or review room and line clearances
- Makes 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 floor
- Reviews and may approve manufacturing analytical testing on the floor
- Uses analytical skills to help ensure shop floor compliance to internal standards and procedures
- Draft and review Standard Operating Procedures
- Work independently and with minimal supervision
- Provides excellent communication
- 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.
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 preferred
- 3-5 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 Integrity
- Knowledge 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 options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- Eligibility for potential yearly Bonus & Merit-Based Pay Increases
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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