Quality Assurance Specialist
4 weeks ago
Catalent Inc. is a global leader in the development and manufacturing of pharmaceutical products. We are currently seeking a highly skilled Quality Assurance Specialist to join our team.
About the Role:
The successful candidate will be responsible for providing quality assurance support for GMP manufacturing of master/working cell banks, biological bulk drug substance, and finished drug product. This will include providing QA on-the-floor oversight of manufacturing, observing critical processes, reviewing batch documentation in real-time, and identifying and implementing continuous improvement initiatives.
Requirements:
- Masters' degree in a scientific, engineering, or biotech field with 2+ years' experience in Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry;
- Familiarity with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines, and EU GMPs;
- Knowledgeable about electronic systems, including developing and producing reports using Microsoft products;
- Excellent analytical, troubleshooting, and decision-making skills;
- Able to work in a team setting and independently under supervision;
- Ability to produce results in a fast-paced environment to meet client deadlines;
- Familiarity with LIMS, EDMS, and Trackwise knowledge preferred.
Benefits:
- Competitive salary range: $93,280 - $128,260 per annum plus shift differential and annual bonus when eligible;
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