Senior Quality Assurance Specialist
4 weeks ago
Catalent Inc. is a leading contract development and manufacturing organization (CDMO) dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers.
As a Senior Quality Assurance Specialist at Catalent Inc., you will be responsible for providing quality assurance support for GMP manufacturing of master/working cell banks, biological bulk drug substance, and finished drug product.
The role requires 80% on-floor time, observing manufacturing operations, reviewing documentation for compliance, and continuously monitoring systems and procedures to ensure regulatory and industry standards are met.
You will work in a team setting and independently under supervision, requiring strong analytical, troubleshooting, and decision-making skills.
Key responsibilities include:
- Providing QA oversight for client projects, including room release, observing critical processes, and reviewing batch documentation
- Performing acceptable quality limit (AQL) visual inspection of drug product and reviewing batch documents for media and buffer prep solutions
- Generating or revising GMP documentation, such as SOPs, Master Batch Records, and SMPs
- Auditing manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices
**Benefits:** Competitive salary range $93,280-$128,260 plus shift differential and annual bonus, when eligible. Enjoy a dynamic work environment, defined career path, and opportunities for growth with a global leader in the pharmaceutical industry.
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Senior Quality Assurance Specialist
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Harmans, Maryland, United States Catalent Inc Full timeCatalent Inc. is a leading contract development and manufacturing organization (CDMO) with a mission to develop, manufacture, and supply products that help people live better and healthier lives.As a Senior Quality Assurance Specialist at Catalent Inc., you will be responsible for ensuring the highest quality standards are met in our analytical operations....
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Quality Assurance Specialist
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Batch Disposition Quality Assurance Specialist
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Harmans, Maryland, United States Catalent Inc Full timeThe estimated annual salary for this position in Maryland is $93,280 - $128,260, plus an annual bonus when eligible. This role involves providing Quality Assurance support for GMP documentation of master/working cell banks, bulk drug substance, and finished drug product.
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Harmans, Maryland, United States Catalent Inc Full timeKey ResponsibilitiesConduct critical reviews of GMP documentation associated with materials control by exercising judgement within defined procedures and regulations.Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of...
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