Jobs · Administrative · Pennsylvania

GMP Compliance Video Reviewer

KVK Tech, Inc. · Newtown, PA · 6 mo ago
AdministrativeFull-time

Responsibilities

  • 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.

Requirements

  • A High School Diploma or equivalent required.
  • An 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.
  • 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.

Qualifications

  • Effective written and verbal communication skills and basic proficiency with computer systems used for documentation and video review.

Skills

  • Highly detail-oriented.
  • Organizational skills.
  • Ability to perform accurate, independent desk-based QA review work.

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

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