QA Batch Record Reviewer (3-11:30pm; Pharma Exp. Required)

QA Batch Record Reviewer

About KVK Tech

KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer dedicated to developing and producing high-quality, FDA-approved medicines that improve patient lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech operates fully within the United States, ensuring quality and consistency through strict adherence to cGMP and regulatory requirements. Our commitment to excellence is rooted in precision, compliance, and a shared mission to provide affordable, life-improving pharmaceutical products.

What You’ll Do

The QA Batch Record Reviewer is responsible for ensuring that manufacturing and packaging documentation is complete, accurate, and compliant with cGMP standards, FDA data integrity expectations, and company procedures. This role provides critical Quality Assurance oversight of documentation used to support product release by verifying that production and packaging activities were properly executed, reviewed, and recorded.

In addition to batch record review, this position will also support GMP compliance video review as an added quality oversight activity. This includes reviewing recorded video of manufacturing and packaging processes to help confirm that procedures were followed, critical steps were performed appropriately, and potential GMP concerns are identified and escalated. The role requires strong attention to detail, sound judgment, and the ability to objectively review both written records and process activity for compliance.

Key Responsibilities

• Review completed batch production and packaging records for accuracy, completeness, and compliance with cGMP, SOP, and company documentation requirements.
• Verify signatures, initials, dates, yields, reconciliations, calculations, material usage, equipment records, cleaning records, and line clearance documentation.
• Review recorded manufacturing and packaging process video to support GMP compliance oversight and confirm that activities were performed in accordance with approved procedures.
• Identify and document discrepancies, omissions, documentation errors, process concerns, or potential deviations observed during batch record review or video review.
• Escalate questionable or non-compliant observations to QA management, Operations, Packaging, Manufacturing, or other appropriate personnel for further review.
• Track and maintain batch record review status within applicable quality systems, databases, logs, or tracking tools.
• Support investigations, deviations, CAPAs, and product release activities by providing accurate, traceable source documentation and video review observations as required.
• Ensure records and review activities adhere to FDA data integrity principles, including ALCOA expectations: attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.
• Assist with authoring, reviewing, and processing controlled documents, SOPs, forms, and validation-related documentation within MasterControl or other document management systems.
• Maintain control, organization, and traceability of batch records throughout review, approval, correction, and archival stages.

What We’re Looking For

Experience:
1–3 years of experience in Quality Assurance, batch record review, documentation review, manufacturing, packaging, or another cGMP-regulated pharmaceutical or related environment preferred.

Education:
High school diploma or equivalent required; Associate degree or higher in Life Sciences, Chemistry, Biology, Pharmaceutical Sciences, or a related technical discipline preferred.

Skills & Knowledge

• Understanding of cGMP documentation practices, batch record review, and FDA data integrity expectations.
• Ability to review documents and recorded process activity with strong attention to detail, objectivity, and consistency.
• Ability to detect documentation errors, calculation issues, missing information, procedural concerns, and potential GMP discrepancies.
• Familiarity with manufacturing, packaging, line clearance, cleaning documentation, material reconciliation, and equipment log review preferred.
• Proficiency in Microsoft Office, including Word, Excel, and Outlook.
• Familiarity with electronic quality systems or document management systems such as MasterControl preferred.
• Strong written and verbal communication skills, including the ability to clearly document and escalate observations.
• Strong organization and time management skills with the ability to manage multiple batch records and deadlines.
• Ability to work independently while knowing when to escalate questions or concerns.
• Commitment to quality, accuracy, compliance, and data integrity.

What We Offer

• Competitive hourly rate with annual performance bonus eligibility
• Annual merit-based pay increases
• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
• Paid Time Off
• 10 paid company holidays
• Comprehensive medical, dental, vision, and life insurance coverage
• Professional development reimbursement
• Career growth opportunities
• Tuition reimbursement for children and childcare expense reimbursement

Schedule

• This position will start during 1st shift (7a - 3:30p) and eventually move to 2nd shift (3:30p - 12a).