QA Batch Record Lead

American Regent; New Albany (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

American Regent is seeking a QA Batch Record Supervisor to ensure quality across batch records and compliance with cGMP. You will lead a team of reviewers, coordinate with manufacturing and QA, and drive timely product releases while maintaining audit-ready documentation.

The role requires leadership experience in a regulated environment, strong analytical skills, and the ability to mentor teammates in a collaborative setting within a sterile pharmaceutical context.

Qualifications

• 5+ years in a GMP/regulatory environment (QA, Compliance, Auditing).
• Minimum 1 year leadership experience.
• Strong attention to detail and audit readiness.
• Ability to train and mentor teammates.
• Knowledge of FDA guidance, ICH, PIC/S and related QA concepts.
• Proficient reading and writing in Standard English; clear documentation.

Responsibilities

• Supervise QA Batch Record Reviewers (I, II, III) and manage workflow.
• Coordinate with cross-functional teams to resolve issues.
• Plan schedules to meet product release deadlines.
• Support CAPAs, investigations, and change requests.
• Mentor staff and provide performance feedback.
• Ensure compliant documentation per SOPs and cGMPs.

Skills

Leadership

QA Compliance

cGMP Knowledge

Documentation

Cross-functional

Analytical Thinking

Education

Bachelor's degree in Science

HS Diploma or GED

Tools

MS Word

Excel

Job description

American Regent is seeking a QA Batch Record Supervisor to ensure quality across batch records and compliance with cGMP. You will lead a team of reviewers, coordinate with manufacturing and QA, and drive timely product releases while maintaining audit-ready documentation.

The role requires leadership experience in a regulated environment, strong analytical skills, and the ability to mentor teammates in a collaborative setting within a sterile pharmaceutical context.