QA Batch Record Lead – GMP Compliance & Review

americanregent; New Albany (OH); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Competitive 401(k)

Job summary

American Regent is seeking a QA Batch Record Supervisor to ensure quality in assigned areas, oversee batch record reviews, and guide reviewers for GMP-compliant documentation.

You will lead training, support CAPA investigations, and collaborate across departments to meet product release timelines while upholding safety and quality standards. This role requires strong leadership and meticulous attention to detail in a regulated manufacturing environment in Ohio.

Qualifications

• Minimum 5+ years in a regulated environment (QA, Compliance, Auditing, Laboratory or Inspection) within GMP.
• Experience in a leadership role for 1+ year and ability to mentor others.
• Strong understanding of quality assurance principles and regulatory documents.

Responsibilities

• Maintain quality objectives and verifications, identify batch record gaps, and escalate issues.
• Supervise QA Batch Record Reviewers (I-III) including scheduling, coaching and mentoring.
• Partner with cross-functional teams to resolve discrepancies and support product release.
• Plan schedules to meet deadlines and ensure compliance with SOPs and cGMP.
• Submit error-free batch records and Change Requests; support CAPA investigations.

Skills

QA leadership

GMP/regulatory knowledge

SOP compliance

Quality Systems

Mentoring/training

Cross-functional collaboration

Education

Bachelor's degree in Science

High School diploma or GED

Tools

MS Word

MS Excel

Job description

American Regent is seeking a QA Batch Record Supervisor to ensure quality in assigned areas, oversee batch record reviews, and guide reviewers for GMP-compliant documentation.

You will lead training, support CAPA investigations, and collaborate across departments to meet product release timelines while upholding safety and quality standards. This role requires strong leadership and meticulous attention to detail in a regulated manufacturing environment in Ohio.