Senior Quality Assurance Specialist

4 weeks ago


Harmans, Maryland, United States Catalent Inc Full time

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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