QA Team Lead - Investigations, CAPA & Compliance

Regulatory Jobs; Winchester (KY); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition Reimbursement

Paid time off and holidays

Job summary

Catalent’s Winchester, KY site is seeking a Supervisor, Quality Assurance to lead QA activities, ensure compliance with quality systems, and support regulatory inspections and audits. The role involves supervising QA Associates and maintaining SOPs, CAPA, and change control processes onsite.

The position emphasizes strong document control, investigation skills, and collaboration across departments to sustain high quality standards at a flagship manufacturing site.

Qualifications

• Bachelor's degree with related work experience or equivalent (2+ years for BS, 3+ years for A.A., 4+ years for HS).
• Batch review and cGMP experience totaling 2+ years.
• Strong analytical and investigative skills.
• Proficiency in English communication and MS Office.

Responsibilities

• Ensure Quality systems comply with procedures and industry standards, including reviews, investigations, CAPA, and training.
• Supervise the Quality Assurance Associates.
• Participate in regulatory inspections and customer audits.
• Author and maintain SOPs for Winchester’s Quality Systems.
• Facilitate investigations and root-cause analysis; manage CAPA tracking.

Skills

Leadership

TrackWise

Quality Systems

Investigations

Education

Bachelor's Degree in Life Science

Tools

TrackWise

Documentum

Job description

Catalent’s Winchester, KY site is seeking a Supervisor, Quality Assurance to lead QA activities, ensure compliance with quality systems, and support regulatory inspections and audits. The role involves supervising QA Associates and maintaining SOPs, CAPA, and change control processes onsite.

The position emphasizes strong document control, investigation skills, and collaboration across departments to sustain high quality standards at a flagship manufacturing site.