Technical Reviewer; QC Lab

KVK Tech is seeking a detail-oriented Technical Reviewer to join our team in Newtown, PA.

The Technical Reviewer will review laboratory data, calculations, electronic records, and analytical reports to ensure accuracy, completeness, and compliance with approved procedures and cGMP requirements. Reporting to the Associate Director of QMS within Quality Assurance, this role supports the reliability of analytical data used for raw material, finished product, and stability testing. The ideal candidate will demonstrate a strong scientific foundation, excellent attention to detail, and an interest in pharmaceutical quality and laboratory data review.

Recent graduates are encouraged to apply; training will be provided, with progression to independent review responsibilities following completion of required training and qualification.

• Review laboratory raw data, worksheets, electronic records, and analytical reports for accuracy, completeness, traceability, and compliance with approved methods, specifications, and procedures.
• Verify analytical calculations, sample and standard preparations, testing conditions, and reported results against original supporting data and applicable acceptance criteria.
• Evaluate chromatographic and other analytical data, including HPLC, GC, dissolution, and related testing, within assigned training and qualifications.
• Review relevant electronic audit trails and supporting documentation to verify that data changes, reprocessing, repeat testing, and excluded results are appropriately documented and justified.
• Identify and promptly elevate out-of-specification (OOS), out-of-trend (OOT), atypical results, documentation deficiencies, and potential data integrity concerns.
• Document review findings, communicate discrepancies to laboratory personnel, and verify that corrections and outstanding issues are appropriately addressed before completing review or authorized approval.
• Support review of method validation, transfer, stability documentation, and laboratory investigations.

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a closely related scientific discipline required.
• 0–2 years of experience in a pharmaceutical, analytical, or other scientific laboratory; relevant academic laboratory experience is welcome, and prior pharmaceutical industry or formal data review experience is not required.
• Foundational understanding of analytical chemistry, scientific calculations, and laboratory documentation.
• Academic, internship, or professional exposure to analytical techniques such as HPLC, GC, UV-Vis, dissolution, or titration preferred.
• Strong analytical, organizational, and documentation review skills, including the ability to recognize discrepancies and follow detailed procedures.

• 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.