Senior Associate - Quality Assurance Operations; 2nd Shift

Senior Associate I - Quality Assurance Operations (2nd shift)

Work Schedule:

Wed–Sat 2pm–12pm
100% on-site

Working for Catalent Biologics offers an opportunity to join an entrepreneurial team with significant investments in people and capabilities. This unique opening is part of a small, fast‑growing business backed by a global public company. Employees have the chance for career development as the business expands.

• Accountable for execution of the QA on the Floor program.
• Performs routine walkthroughs of the Manufacturing Area partnering with manufacturing on quality best practice implementation and troubleshooting when problems arise.
• Provides direct quality support for routine manufacturing operations.
• Responsible issuance of controlled documents for production, including Batch Production Records, Product Labels and forms.
• Responsible for review of documentation, including batch records, test data, environmental monitoring data, and logbooks, for production of solutions and columns used in the manufacture of bulk drug substance.
• Performs release of produced solutions and columns.
• Assists with inspection of final product containers.
• Supports shipment of finished products.
• Responsible for review of facility and equipment records in support of GMP operations.
• Accountable for control and management of Cell Bank inventory.
• Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Performs or supports any other tasks necessary to maintain product quality and site CGMP compliance.
• Files and maintains controlled documents.
• Other duties as assigned.

• Master’s degree in STEM discipline with minimum of 0 years related experience.
• Bachelor’s Degree in STEM discipline with minimum of 3 years related experience.
• Associate’s Degree in STEM discipline with minimum of 6 years related experience.
• High School Diploma with a minimum of 7 years related experience.

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Positive working environment focusing on continually improving processes to remain innovative.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• 152 hours of PTO + 8 paid holidays.
• Generous 401K match.
• Medical, dental and vision benefits effective day one of employment.
• Tuition Reimbursement – Let us help you finish your degree or start a new degree!

Catalent is an Equal Opportunity Employer, including disability and veterans.