KVK Tech, Inc.
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GMP Compliance Video Reviewer
role at
KVK Tech, Inc.
The company 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.
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.
Qualifications
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.
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
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.
Seniority level: Entry level
Employment type: Full‑time
Job function: Administrative
Industry: Pharmaceutical Manufacturing
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GMP Compliance Video Reviewer
role at
KVK Tech, Inc.
The company 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.
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.
Qualifications
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.
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
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.
Seniority level: Entry level
Employment type: Full‑time
Job function: Administrative
Industry: Pharmaceutical Manufacturing
#J-18808-Ljbffr