Quality Assurance Associate , Analytical at Catalent Pharma Solutions San Diego, CA

Quality Assurance Associate I, Analytical

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) dedicated to delivering unparalleled service to pharmaceutical, biotech, and consumer health customers. Catalent Pharma Solutions in San Diego focuses on bringing client drug compounds from discovery to the clinic through analytical development, pre-formulation testing, formulation development, GMP manufacturing, and stability storage and testing.

• Review and approve controlled documents such as SOPs, CPPs, protocols, test methods, and specifications.
• Review analytical release and stability data with minimal supervision.
• Review and approve OOS and variance documentation under supervision.
• Support manufacturing activities including line clearance, label quarantine/release, cleaning verification review, and raw material release data review.
• Assist in internal, external, and client audits.
• Perform other duties as assigned.

• Bachelor’s degree required (preferably in Chemistry or Biochemistry).
• Minimum of 1 year of applicable GMP industry experience in analytical, QC, manufacturing, or QA settings.
• High preference for experience with HPLC, HPLC data review, and quality systems such as Trackwise and Empower.

• Ability to walk, sit, stand, use hands, reach with arms and hands at or above shoulder height, below waist height, climb or balance, stoop, kneel, crouch, or crawl.
• Talk and hear, smell, and lift up to 15 pounds.
• Visual inspection of materials and use of computer monitor screen frequently.

• Annual salary range: $65,000 - $70,000, depending on experience and qualifications.

• Comprehensive medical, dental, and vision coverage effective day one.
• Generous 401(k) match and PTO accrual with 152 hours of PTO and 10 paid holidays.
• Paid time off and bonus potential.
• Tuition reimbursement and Well Hub wellness program.
• Employee resource groups focusing on diversity and inclusion.

Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, please submit your request by email, including the job number, title, and location, to Disabili