Technical Reviewer (QC Lab)

KVK Tech, Inc.; Newtown (PA); Presencial; USD 55.000 - 75.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

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

Descripción de la vacante

KVK Tech, Inc. in Newtown, PA seeks a detail-oriented Technical Reviewer to validate laboratory data, calculations, electronic records, and analytical reports for accuracy, completeness, and cGMP compliance.

Reporting to the Associate Director of QMS within Quality Assurance, the role supports data integrity for raw material, finished product, and stability testing, with training and progression to independent review. Recent graduates are encouraged to apply, with comprehensive training provided.

Formación

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a closely related scientific discipline.
• 0–2 years of experience in a pharmaceutical, analytical, or scientific laboratory.
• Foundational understanding of analytical chemistry, calculations, and laboratory documentation.
• Experience with analytical techniques such as HPLC, GC, UV-Vis, dissolution, or titration is preferred.
• Strong analytical, organizational, and documentation review skills.

Responsabilidades

• Review laboratory raw data, worksheets, electronic records, and reports for accuracy and compliance.
• Verify calculations, sample and standard preparations, testing conditions, and reported results against data.
• Evaluate chromatographic and other analytical data, including HPLC, GC, and dissolution.
• Review electronic audit trails to verify data changes and justification.
• Identify and elevate out-of-specification or out-of-trend results and data integrity concerns.
• Document review findings and communicate discrepancies to laboratory personnel.
• Support review of method validation, transfer, stability documentation, and investigations.

Conocimientos

Analytical chemistry

Documentation review

Attention to detail

Educación

Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or closely related scientific discipline

Herramientas

HPLC

GC

UV-Vis

Dissolution

Titration

Descripción del empleo

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.

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

• 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.

We Are Looking For Applicants With

• 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.

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.