Quality Assurance Associate

Quality Assurance Associate

Position Summary

Typical Working Hours are 2nd Shift (Monday-Friday 2 PM-10:30 PM).

This position is 100% on-site in Winchester, Kentucky.

Catalent's Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry-leading Glatt technology.

The Quality Assurance Associate is responsible for the Quality support functions associated with the manufacturing of solid oral dosage products for a given business unit. The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and Catalent SOP) through document review/approval, real time monitoring/approval of manufacturing activities and testing/approval of in-process and finished product samples.

The Role

• Recommend SOP and batch record changes as needed. Review proposed SOP revisions and provide feedback to management.
• Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters
• Perform room and equipment clearances per procedure following cleaning conducted by production. Perform microbial swabbing of equipment and room surfaces for environmental monitoring.
• Maintain a full understanding of all Catalent SOPs and policies along with all cGMP and CFR guidance that are applicable to the manufacturing of solid oral dosage pharmaceutical products.
• Perform routine testing of in-process and finished product samples including particle size, bulk density, moisture analysis, appearance, and AQL testing real-time.
• Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements in order to identify and resolve routine errors and prevent possible deviations that affect production real-time.
• Initiate deviation problem reports in Trackwise for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the responsible department can be conducted.
• Assist in investigations for deviations by supporting data gathering and root cause analysis.
• Other duties as required in support of Catalent Pharma Solutions high performance.

The Candidate

• Bachelors degree; OR Associates with 1 year of related work experience; OR High School Diploma/GED with 2 years of related work experience
• Lean Six Sigma, ASQ certification or other professional certification preferred.
• Individual may be required to sit and stand for an extended period of time. Specific vision requirements include reading of written documents and frequent use of computer monitor.

Why You Should Join Catalent

• Several Employee Resource Groups focusing on D&I
• Tuition Reimbursement – Let us help you finish your degree or earn a new one!
• Generous 401K match
• 152 hours accrued PTO + 8 paid holidays

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.

Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Personal initiative. Dynamic pace. Meaningful work.

Visit Catalent Careers to explore career opportunities.

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