GMP Compliance Video Reviewer

3 hours ago

Newtown Grant, Pennsylvania, United States KVK Tech, Inc. Full time

KVK Tech is seeking a detail-oriented GMP Compliance Video Reviewer to join our Quality Assurance team in Newtown, PA.
The GMP Compliance Video Reviewer provides independent QA oversight through the review of recorded manufacturing and packaging video footage to verify compliance with approved batch records, SOPs, and cGMP requirements. This role plays a critical part in ensuring that documented production activities accurately reflect what occurred on the production floor, supporting data integrity, deviation identification, and inspection readiness within a regulated pharmaceutical manufacturing environment.

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

  • Review recorded video footage of manufacturing and packaging operations to confirm activities were performed in accordance with approved batch records, SOPs, and cGMP requirements.
  • Compare video evidence against batch documentation to verify accuracy of critical process steps, material handling, line clearance activities, and recorded timestamps.
  • Document observations, discrepancies, and potential nonconformances identified during video review in accordance with Quality Assurance documentation practices.
  • Escalate observed deviations, documentation inconsistencies, or potential data integrity concerns to QA management in a timely manner.
  • Maintain organized, contemporaneous records of video review activities to support investigations, audits, and regulatory inspections.
  • Collaborate with Manufacturing, Packaging, and Quality Assurance personnel to clarify process steps and documentation questions identified during review.
  • Support internal audits, regulatory inspections, and continuous improvement initiatives by providing video-based compliance evidence when requested.

We Are Looking For Applicants With

  • High School Diploma or equivalent required; Associate degree in Life Sciences, Quality, or a related technical discipline preferred.
  • 1–3 years of experience in a cGMP-regulated pharmaceutical manufacturing environment required.
  • Prior hands-on experience in oral solid dosage (OSD) manufacturing, packaging, or Quality Assurance strongly preferred.
  • Working knowledge of batch records, manufacturing documentation, and packaging processes.
  • Familiarity with FDA data integrity principles, including ALCOA+, and GMP documentation practices.
  • Strong attention to detail, organizational skills, and ability to perform accurate, independent desk-based QA review work.
  • Effective written and verbal communication skills and basic proficiency with computer systems used for documentation and video review.

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.

Apply for this position

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