QA Chemist

KVK Tech is seeking a QA Chemist to join our team in Newtown, PA.

The QA Chemist will ensure the accuracy, completeness, and regulatory compliance of analytical laboratory data through systematic, scientifically sound review practices. This role verifies adherence to test methods, SOPs, specifications, validation requirements, and cGMP/data integrity standards while identifying discrepancies, trends, and opportunities for correction or improvement. The ideal candidate will demonstrate strong analytical expertise, experience with laboratory data review, and the ability to partner with QC staff to support compliant documentation, timely investigations, and inspection readiness.

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

• Review analytical raw data, chromatographic sequences, laboratory notebooks, and calculations for scientific accuracy and cGMP compliance.
• Evaluate analytical documentation supporting method development, validation, release testing, stability studies, and investigations.
• Verify adherence to approved specifications, SOPs, protocols, and data integrity expectations (ALCOA+).
• Identify discrepancies or atypical results and provide clear, actionable feedback to QC analysts and supervisory staff.
• Approve analytical protocols, validation reports, stability summaries, and related controlled documents within QA review authority.
• Collaborate with QC, QA, and cross-functional partners to resolve data issues, support root-cause analyses, and ensure timely documentation.
• Support audit and inspection readiness by preparing data packages and ensuring records are accurate, complete, and easily retrievable.

We are looking for applicants with:

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field; Master’s degree preferred.
• Minimum 2 years of experience in a GMP-regulated pharmaceutical environment, ideally within QA or QC.
• Hands-on experience performing or reviewing analytical data, including HPLC/GC/UV methods and laboratory documentation.
• Strong working knowledge of cGMP, ICH guidelines, FDA requirements, and data integrity principles (ALCOA+).
• Excellent attention to detail, documentation accuracy, and communication skills, with proficiency in Microsoft Office and familiarity with chromatography data systems (e.g., Empower, Chromeleon).

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.

We encourage you to apply if you feel that you are a match! We look forward to hearing from you.