Onsite Quality Assurance Lead – GMP & CAPA

Catalent, Inc.; Winchester (KY); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Competitive PTO

8 paid holidays

Medical, dental, vision benefits

Tuition Reimbursement

Job summary

Catalent's Winchester, KY site seeks a Supervisor, Quality Assurance to lead the QA team, ensure GMP compliance, batch release, and change control. The role supports regulatory inspections, audits, CAPA and continuous improvement initiatives in a 100% onsite environment.

Ideal candidates have a Bachelor's degree with 2+ years of related experience, strong analytical and writing skills, and proficiency in TrackWise and Microsoft Office; Catalent leadership experience is a plus.

Qualifications

• Bachelor’s Degree with 2+ years of related work experience; or equivalent.
• Batch review and cGMP experience totaling 2+ years.
• Strong analytical and investigative skills.
• Proficient in English verbal and written communication.
• Proficiency in MS Word, PowerPoint, Excel, and Access.
• Leadership experience at Catalent is a plus; may replace external exp.
• TrackWise Quality Management System experience.

Responsibilities

• Ensure Quality systems comply with procedures and standards.
• Supervise the Quality Assurance Associates.
• Participate in Regulatory (FDA) inspections and customer audits.
• Author and maintain SOPs for Winchester’s Quality Systems.
• Facilitate investigations, root cause analysis, CAPA, and APR.
• Manage documentation of CAPA commitments and trends.
• Recommend process changes based on CAPA and CAPA data.
• Serve as QA liaison to other departments and customers.
• Act as SME for TrackWise, Documentum, and other QA software.
• Communicate HR policies within the department.
• Maintain employee performance documentation and timekeeping.
• Ensure adherence to GMP and Quality policies.
• Propose and enforce quality improvements.
• Perform other duties as required.

Skills

Strong analytical and investigative

English communication skills

Leadership experience

TrackWise Quality Management System

Education

Bachelor's Degree or higher

Tools

Microsoft Word

PowerPoint

Excel

Access

Job description

Catalent's Winchester, KY site seeks a Supervisor, Quality Assurance to lead the QA team, ensure GMP compliance, batch release, and change control. The role supports regulatory inspections, audits, CAPA and continuous improvement initiatives in a 100% onsite environment.

Ideal candidates have a Bachelor's degree with 2+ years of related experience, strong analytical and writing skills, and proficiency in TrackWise and Microsoft Office; Catalent leadership experience is a plus.