Supervisor, Quality Assurance

Catalent • Winchester, KY

7d • Onsite

About The Position

The Supervisor, Quality Assurance provides leadership within the Quality Assurance function at Catalent’s Winchester, Kentucky site. The role oversees compliance with Quality Systems, finished product batch release, and change control, and supports regulatory inspections, customer audits, and continuous improvement initiatives. The supervisor also serves as a Quality department liaison and subject matter expert for other departments, customers, and regulatory representatives.

The position is onsite Monday through Friday from 2:00 PM to 10:30 PM. It supervises Quality Assurance Associates and helps ensure the site’s Quality Systems comply with corporate and site procedures, industry standards, current Good Manufacturing Practices, company Quality Policies, and site Standard Operating Procedures.

Requirements

• Bachelor’s degree and at least 2 years of related work experience; or an Associate degree and at least 3 years of related work experience; or a high school diploma/GED and at least 4 years of related work experience.
• At least 2 years of combined batch review and cGMP experience.
• Strong analytical and investigative skills.
• Proficient English verbal and written communication skills to convey and receive ideas and instructions within and outside the organization.
• Proficiency in Microsoft Word, PowerPoint, Excel, and Access.

Nice To Haves

• Prior supervisory or management experience; the role will immediately have 5 direct reports.
• TrackWise Quality Management System experience.
• Strong technical writing skills for investigations, deviations, Corrective and Preventive Actions, and root cause analysis.
• Bachelor’s degree in Life Science.
• Demonstrable leadership experience at Catalent, including participation in company-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW, may be considered in place of external experience.

Responsibilities

• Ensure Quality Systems comply with corporate and site procedures and industry standards, including those related to Annual Product Reviews, Complaints, Investigations, Corrective and Preventive Actions, and Training.
• Supervise Quality Assurance Associates.
• Participate in FDA regulatory inspections and customer audits.
• Author and maintain detailed Standard Operating Procedures defining Winchester’s Quality Systems.
• Facilitate investigations, root cause analysis, the Complaints process, and the Annual Product Review process.
• Manage and track documentation of Corrective and Preventive Action commitments and related trending processes.
• Recommend process changes based on trends from CAPA, Complaints, and Annual Product Reviews.
• Serve as the Quality department liaison and subject matter expert to other departments, customers, and regulatory representatives.
• Act as a subject matter expert in TrackWise, Documentum, and other Quality software platforms.
• Communicate and implement Human Resources policies within the department.
• Maintain documentation related to employee performance and timekeeping, and administer discipline as appropriate in coordination with Human Resources.
• Ensure adherence to quality standards governed by current Good Manufacturing Practices, company Quality Policies, and site Standard Operating Procedures.
• Propose, implement, and enforce quality improvements.
• Perform other duties as required.

Benefits

• Competitive paid time off and 8 paid holidays.
• Medical, dental, and vision benefits effective on the first day of employment.
• Tuition reimbursement.
• Site-based employee engagement activities.
• Employee Resource Groups focused on diversity and inclusion.
• Environmentally friendly community engagement initiatives.
• Defined career path with annual performance reviews and growth potential.
• WellHub program promoting physical and mental wellness.
• Perkspot discounts from more than 900 merchants.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager