QA Batch Record Reviewer

Piper Companies is seeking a QA Batch Record Reviewer to join its team in Audubon, PA. This role is responsible for reviewing batch documentation and supporting product release activities to ensure compliance with current Good Manufacturing Practices (cGMP) and internal quality standards.

Key Responsibilities

• Review and approve executed batch records to support product release, ensuring accuracy, completeness, and compliance
• Evaluate and approve Master Batch Records and minor document changes, collaborating with internal teams and clients to meet timelines
• Support investigations related to batch deviations and complaints, ensuring timely resolution and proper documentation
• Partner with clients to maintain quality expectations, including participation in meetings and ongoing communication
• Contribute to quality metrics, KPIs, Annual Product Reviews (APRs), and risk assessments to identify trends and support continuous improvement
  
  

Required Qualifications

• High School Diploma required
• 2 years of experience in pharmaceutical Quality Assurance
• Experience in manufacturing or packaging environments
• Working knowledge of cGMP regulations and compliance standards
• Experience reviewing and auditing GMP documentation
  
  

Compensation & Benefits

• Flexible Pay ($25 /HR)
• Comprehensive medical, dental, and vision coverage (effective first of the month following start)
  
  

Keywords: QA, Quality Assurance, Batch Record Review, Batch Records, Executed Batch Records, Master Batch Records, cGMP, GMP, Pharmaceutical Quality, Pharma, Packaging, Manufacturing, Product Release, Document Review, Document Control, Deviation Management, CAPA, Investigations, Complaints Handling, Quality Systems, Quality Metrics, KPIs, Annual Product Review, APR, Risk Assessment, Regulatory Compliance, FDA Regulations, Audit, GMP Auditing, SOPs, Quality Documentation, Continuous Improvement, Client Interaction