Quality Assurance Associate

Catalent Pharma Solutions • Winchester, KY

11d • Onsite

About The Position

We have an opportunity for a Quality Assurance Associate to join our team. In this role, you will provide quality support for the manufacturing of solid oral dosage products. You will review and approve documents, monitor manufacturing activities in real time, and test in-process and finished product samples to ensure compliance with cGMP, CFR, and company procedures. This position is key to maintaining high standards of quality and safety in our operations.

Requirements

• 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

Nice To Haves

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

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

Benefits

• Competitive Paid Time Off plus 8 paid holidays
• Medical, dental, and vision benefits effective day one of employment
• Tuition Reimbursement
• Site-based Employee Engagement activities
• Employee Resource Groups
• Environmentally friendly, community engagement green initiatives
• Defined career path and annual performance review process with potential for career growth
• WellHub program to promote overall physical and mental wellness
• Perkspot offers exclusive discounts

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED