QA Compliance Lead - Pharmaceutical Manufacturing

Catalent Pharma Solutions; Winchester (KY); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Competitive PTO and holidays

Medical, dental, and vision benefits

Job summary

Catalent Pharma Solutions in Winchester, KY is seeking a Supervisor, Quality Assurance to lead and oversee QA activities within a 100% onsite role. The position focuses on ensuring compliance with Quality Systems, batch release, and change control, while supporting regulatory inspections and customer audits.

The ideal candidate will supervise QA Associates, author SOPs, participate in investigations, CAPAs, and trend analysis, and serve as SME for QA software platforms, with strong communication

Qualifications

• Bachelor’s Degree with 2+ years of related work experience or Associate Degree with 3+ years, or High School Diploma with 4+ years.
• Batch review and cGMP experience totaling 2+ years.
• Strong analytical and investigative skills.
• Proficient in English verbal and written communication.
• Proficiency in Microsoft Word, PowerPoint, Excel, and Access.
• Demonstrable leadership experience at Catalent preferred.
• TrackWise Quality Management System experience is a plus.
• Experience with Documentum or other quality software platforms.

Responsibilities

• Ensure Quality systems comply with corporate/site procedures and industry standards (including APRs, Complaints, Investigations, CAPAs, and Training).
• Supervise the Quality Assurance Associates.
• Participate in Regulatory (FDA) inspections and customer audits.
• Author and maintain SOPs defining Winchester’s Quality Systems.
• Facilitate investigations, root cause analysis, and CAPA processes.
• Manage documentation of CAPA commitments and related trending.
• Recommend process changes based on CAPA/Complaints/APRs trends.
• Serve as QA liaison to other departments, customers, and regulators.
• Act as SME for TrackWise, Documentum, and other QA software platforms.
• Communicate HR policies within the department and assist with performance documentation and discipline as needed.
• Ensure adherence to cGMP and site quality policies and SOPs.
• Propose and enforce quality improvements; perform other duties as required.

Job description

Catalent Pharma Solutions in Winchester, KY is seeking a Supervisor, Quality Assurance to lead and oversee QA activities within a 100% onsite role. The position focuses on ensuring compliance with Quality Systems, batch release, and change control, while supporting regulatory inspections and customer audits.

The ideal candidate will supervise QA Associates, author SOPs, participate in investigations, CAPAs, and trend analysis, and serve as SME for QA software platforms, with strong communication