QA Batch Record Reviewer – 2nd Shift

Responsibilities

• Review completed packaging batch records for oral solid dosage products to ensure compliance with approved master batch records, SOPs, and cGMP requirements.
• Verify documentation accuracy, including entries, calculations, reconciliations, signatures, initials, and dates, in accordance with data integrity (ALCOA+) principles.
• Review supporting documentation such as equipment logs, line clearance records, and component reconciliation records to ensure batch traceability and documentation consistency.
• Identify documentation discrepancies or errors and support deviation documentation and investigation activities as required.
• Track batch record review status and ensure proper routing, approval, and archival within electronic quality systems.
• Support inspection readiness by ensuring batch documentation is complete, accurate, and readily retrievable for internal and regulatory audits.

Requirements

• High school diploma or equivalent required; associate’s degree or higher in a scientific, technical, or quality-related discipline preferred.
• 1–3 years of experience in Quality Assurance, batch documentation review, or pharmaceutical manufacturing within a cGMP-regulated environment.
• Working knowledge of cGMP documentation practices and FDA regulatory expectations.
• Strong attention to detail with the ability to identify documentation discrepancies and compliance risks.
• Proficiency with Microsoft Office and familiarity with electronic quality systems (e.g., MasterControl) preferred.

Qualifications

None specified.

Skills

None specified.

Benefits

• 401(k) with company match
• Health, vision, and dental Insurance
• Childcare expense reimbursement
• Tuition reimbursement
• Annual bonus eligibility
• Annual merit increases
• Paid Time Off and Flexible Holidays

Pay

N/A

Schedule

N/A