QA Supervisor: CAPA, Audits & Compliance Lead

Catalent, Inc.; Winchester (VA); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Competitive PTO and holidays

Medical, dental, Vision benefits from

Tuition reimbursement

Career development programs

Job summary

Catalent, Inc. in Winchester, KY is seeking a Supervisor, Quality Assurance to lead the QA team and ensure compliance with cGMP, batch release, change control, and regulatory inspections.

The role emphasizes investigations, CAPA, SOPs, training, and cross‑functional collaboration to uphold the highest quality standards. The position involves supervising QA associates, participating in FDA inspections, and maintaining robust quality systems in a 100% onsite environment with standard Monday–Friday

Qualifications

• Bachelor's Degree with 2+ years of related work experience; OR Associate Degree with 3+ years; OR High School Diploma/GED 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.
• Leadership experience at Catalent may be considered in place of external experience.

Responsibilities

• Ensure Quality systems comply with procedures and industry standards including Annual Product Reviews, Complaints, Investigations, CAPAs, and Training.
• Supervise the Quality Assurance Associates.
• Participate in Regulatory (FDA) inspections and customer audits.
• Author and maintain SOPs defining Quality Systems.
• Facilitate investigations and root-cause analysis for deviations.
• Manage documentation of CAPA commitments and related trending processes.
• Serve as QA liaison to other departments, customers, and regulators.
• Operate TrackWise, Documentum, and other quality software.

Skills

Leadership

Analytical skills

Investigations

Communication

Education

Bachelor's degree

cGMP experience

Tools

TrackWise

Documentum

Microsoft Word

Excel

PowerPoint

Access

Job description

Catalent, Inc. in Winchester, KY is seeking a Supervisor, Quality Assurance to lead the QA team and ensure compliance with cGMP, batch release, change control, and regulatory inspections.

The role emphasizes investigations, CAPA, SOPs, training, and cross‑functional collaboration to uphold the highest quality standards. The position involves supervising QA associates, participating in FDA inspections, and maintaining robust quality systems in a 100% onsite environment with standard Monday–Friday