QA Batch Record Reviewer – 2nd Shift

KVK Tech is seeking a 2nd Shift QA Batch Record Reviewer to join our team in Newtown, PA.

The QA Batch Record Reviewer is responsible for reviewing executed packaging batch documentation to ensure accuracy, completeness, and compliance with cGMP requirements and internal quality standards. This role plays a critical part in supporting compliant batch documentation, inspection readiness, and the overall effectiveness of the Quality Management System. The ideal candidate will demonstrate strong attention to detail, working knowledge of pharmaceutical documentation practices, and experience supporting Quality Assurance activities within a regulated manufacturing environment.

This position’s responsibilities will include, but not be limited to the following:

• 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.

We are looking for applicants with:

• 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.

What we offer:

• 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

KVK Tech is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status.

We encourage you to apply if you feel that you are a match! We look forward to hearing from you.