Quality Assurance Associate

About the role

Site Catalent’s Winchester, KY site is the company’s flagship U.S. manufacturing location for large-scale oral solid dose forms. The site specializes in complex and controlled-release oral dose technologies, supporting product development, technology transfer, and commercial manufacturing across pharmaceutical and consumer health programs. Winchester has a long commercial manufacturing track record, having launched 100+ products and producing billions of tablets and capsules annually.

Responsibilities

• Recommend Standard Operating Procedure and batch record changes as needed
• Review proposed Standard Operating Procedure revisions and provide feedback to management
• Conduct real-time audits of batch records for completeness, accuracy, and compliance with critical process parameters
• Perform room and equipment clearances after production cleaning activities
• Perform environmental monitoring through microbial swabbing of equipment and room surfaces
• Maintain working knowledge of all applicable Standard Operating Procedures, policies, current Good Manufacturing Practices, and Code of Federal Regulations
• Perform routine testing of in-process and finished product samples, including particle size analysis, bulk density testing, moisture analysis, appearance evaluations, and Acceptable Quality Level testing
• Monitor manufacturing areas to ensure compliance with Standard Operating Procedures, current Good Manufacturing Practices, batch records, and safety requirements
• Identify and resolve routine errors and prevent deviations in real time
• Collaborate cross-functionally to assess potential deviations and determine investigation requirements
• Initiate deviation reports in TrackWise with sufficient documentation for investigation
• Manage quality status of work-in-process and finished goods in both physical inventory and JD Edwards inventory systems
• Support investigations by gathering data and assisting with root cause analysis
• Enforce Good Manufacturing Practice compliance
• Promote teamwork and effective communication
• Provide training and coaching to manufacturing personnel as needed
• Support site process improvements, training initiatives, efficiency projects, and Corrective and Preventive Action implementations
• Investigate customer complaints
• Perform other duties as assigned

Qualifications

• Bachelor's degree; or Associate degree with 1 year of related experience; or High School Diploma/GED with 2 years of related experience
• Familiarity with basic laboratory instrumentation
• Basic math and computer skills
• Strong communication skills and English proficiency
• Excellent documentation and handwriting skills
• Strong reading comprehension skills
• Technical writing skills
• Knowledge of Good Laboratory Practices
• Prolonged sitting, standing, and walking
• Frequent computer use and document review

Skills

• Lean Six Sigma certification
• ASQ certification
• Other relevant professional certifications

Benefits

Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic
Competitive Paid Time Off plus 8 paid holidays
Medical, dental, and vision benefits effective day one of employment
Tuition Reimbursement – support to finish your degree or earn a new one
Site-based Employee Engagement activities such as NCAA Basketball Brackets, Golf Scrambles, Annual Onsite Pet Adoption Events, and Mentorship Partnerships with Local Schools
Employee Resource Groups focusing on Diversity and Inclusion
Environmentally friendly, community engagement green initiatives including Adopt-a-Highway Clean-up
Defined career path and annual performance review process with potential for career growth
WellHub program to promote overall physical and mental wellness