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