What are the responsibilities and job description for the Quality Assurance Engineer position at United Pharma?
Title: QA Batch Record Reviewer (Contract)
Location: Indiana
Our client is looking for a detail-oriented Contract Batch Record Reviewer to assist in clearing a backlog of paper-based batch manufacturing records (BMRs) within the drug product fill/finish domain. This role involves reviewing historical batch documentation to ensure completeness, accuracy, and compliance with cGMP standards, internal SOPs, and global regulatory requirements (FDA, EU, etc.). The ideal candidate will have 3–5 years of relevant industry experience.
Key Responsibilities:
- Review paper-based batch records, including formulation, filling, labeling, and packaging documentation, to ensure compliance with cGMP and internal procedures.
- Identify, document, and help resolve discrepancies, deviations, incomplete entries, or required corrections.
- Collaborate with Quality Assurance (QA), manufacturing, and document control teams to clarify information and address issues.
- Monitor and report progress toward backlog reduction goals.
- Ensure all reviewed records are audit-ready and meet regulatory standards.
- Assist with data entry or support the transition of records into electronic systems, as needed.
- Maintain strict confidentiality and compliance when handling sensitive manufacturing data.
Qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, or a related field preferred; equivalent experience will be considered.
- At least 2 years of experience reviewing batch records in a cGMP-regulated environment, preferably in sterile drug product fill/finish operations.
- Solid knowledge of FDA, EU, and ICH regulatory requirements for pharmaceutical manufacturing.
- Strong attention to detail and a high level of accuracy in documentation.
- Ability to work independently with minimal supervision.
- Excellent written and verbal communication skills.