Senior Quality Assurance Manager

3 weeks ago


Harmans, Maryland, United States Catalent Inc Full time
Job Summary

The Senior Quality Assurance Manager will oversee the Client Support processes and personnel, ensuring staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines. This role will build effective teams that apply their diverse skills and perspectives to achieve common goals, drive engagement, and create a culture where employees are motivated to do their best.

Key Responsibilities

- Supervise Client Support processes and personnel
- Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines
- Build effective teams that apply their diverse skills and perspectives to achieve common goals
- Drive engagement and create a culture where employees are motivated to do their best

Requirements

- Masters' degree in a Scientific, Engineering or Biotech field with 4 – 6 years' experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry
- Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs
- Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish

About Catalent

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Our mission is to help people live better, healthier lives. We are committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

What We Offer

- Competitive medical benefits and 401K
- 152 hours PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement Processes
- Catalent offers rewarding opportunities to further your career

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