QA Batch Records Lead (GMP/Compliance)

AMERICAN REGENT, INC.; New Albany (OH); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

American Regent, Inc. is seeking a QA Batch Record Supervisor to oversee the Batch Record Review group, ensuring compliance with GMP and SOPs while supporting root-cause investigations and process improvements. The role requires leadership of reviewers I–III and collaboration with production and quality teams.

Responsibilities include training, performance coaching, and maintaining audit-ready documentation, with emphasis on cGMP adherence and regulatory familiarity across QA processes.

Qualifikationen

• Bachelor’s degree in Science, preferred.
• Minimum 5+ years in a regulated environment (QA/compliance/audit/Lab) in GMP.
• At least 1 year in a leadership role.
• Strong QA/regulatory knowledge and attention to detail.
• Excellent written and verbal communication; audit-ready.
• Proven ability to mentor junior staff.

Aufgaben

• Lead QA Batch Record Review team and manage scheduling.
• Review batch records for accuracy and compliance with SOPs.
• Collaborate with cross-functional teams on production issues and CAPAs.
• Prepare and review change requests and CAPA investigations.
• Provide training and performance assessment for QA staff.
• Ensure cGMP compliance and adherence to regulatory documents.

Kenntnisse

Leadership

Quality systems

Communication

Auditing

Regulatory knowledge

MS Word

Excel

Ausbildung

Bachelor's degree in Science

Tools

MS Word

Excel

Jobbeschreibung

American Regent, Inc. is seeking a QA Batch Record Supervisor to oversee the Batch Record Review group, ensuring compliance with GMP and SOPs while supporting root-cause investigations and process improvements. The role requires leadership of reviewers I–III and collaboration with production and quality teams.

Responsibilities include training, performance coaching, and maintaining audit-ready documentation, with emphasis on cGMP adherence and regulatory familiarity across QA processes.