- Execute real time review of batch documentation and other manufacturing documentation analyzing for errors, corrections, and compliance
- Transfer Master Cell Banks to Manufacturing
- Monitor and Perform housekeeping and GMP walkthroughs of facility
- Initiate, review, and approve deviations
- Provide quality leadership to 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
- Oversees analytical test results initial investigations on the floor
- Reviews and Approves Manufacturing analytical testing on the floor.
- Uses analytical skills to ensure shop floor compliance to internal standards and procedures
- Oversees and leads Associates and Manufacturing colleagues as needed with non-conformances, deviations, and other issues on the floor.
- Provides training to Associates on job duties, including onboarding
- Work independently and with minimal supervision
- Provides oversight of associates in absence of Manager
- Reviews associate work
- Deliver on the job training
- Makes decisions for escalation of events to deviations
- Support the Manager, MQA in job duties
- Review Master Production Records for use in production
- 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.
- Bachelor's Degree in a relevant discipline (e.g., microbiology, chemistry, biological sciences, bioengineering, etc.). preferred
- 5+ years of experience in Quality Assurance in GMP facilities or equivalent experience, drug substance preferred
- 5+ years of experience with batch record review, housekeeping monitoring, GMP document review and/or creation.
- 5+ years of experience reviewing deviation reports, change controls, CAPA, and analytical data.
- 5+ years of experience with Data Integrity
- 3+ years of decision making related to complex situations.
- 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
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Manufacturing QA Senior Associate - Sanford, United States - Eurofins USA PSS Insourcing Solutions
Description
Job Description
Job DescriptionCompany DescriptionThe 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 Senior Associate provides quality leadership and contributes to Quality Assurance on the floor activities related to drug substance manufacturing. The colleague uses their strong knowledge of GMP to provide quality leadership and oversight of manufacturing documentation, housekeeping, and overall GMP compliance. This is decision making role and provide for creative problem solving. The Senior Associate ensures the site performs in a state of compliance by leading Quality oversight activities while fostering an empowered culture of quality across all functions.
POSITION RESPONSIBILITIES:
ADDITIONAL DUTIES:
BASIC MINIMUM QUALIFICATIONS:
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.
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
