QC Chemist III

About KVK Tech

KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.

What You’ll Do

The QC Chemist III serves as a senior analytical scientist and technical resource within the Quality Control laboratory. This role independently performs and oversees advanced analytical testing, leads method validation and transfer activities, troubleshoots complex laboratory issues, reviews analytical data, and provides scientific support for investigations. The QC Chemist III also mentors less experienced chemists, strengthens laboratory practices, and supports inspection readiness while operating as a senior individual contributor without formal personnel-management responsibilities.

Key Responsibilities:

• Perform advanced and complex analytical testing of raw materials, in-process materials, finished products, and stability samples using HPLC, UPLC, GC, UV-Vis, dissolution, Karl Fischer titration, wet chemistry, and other approved analytical techniques.

• Lead or independently execute assigned analytical method validation, verification, and transfer activities, including protocol execution, data evaluation, technical documentation, and resolution of method-related issues.

• Evaluate and interpret analytical results, identify atypical data or trends, and provide scientific root-cause analysis supporting OOS/OOT investigations, deviations, CAPAs, and laboratory change controls.

• Review and approve laboratory data, calculations, chromatographic results, worksheets, logbooks, and electronic records for accuracy, completeness, scientific validity, and compliance with cGMP, ALCOA, and Data Integrity requirements.

• Qualify, calibrate, maintain, and troubleshoot laboratory instrumentation while authoring or revising associated protocols, SOPs, test methods, work instructions, and equipment records.

• Provide technical guidance, training, and mentorship to junior chemists while collaborating with QA, Manufacturing, Validation, Regulatory Affairs, and other functions to improve laboratory performance and maintain inspection readiness.

What We’re Looking For

Experience:

• Minimum of 6 years of progressively responsible analytical laboratory experience within a cGMP-regulated pharmaceutical Quality Control or closely related pharmaceutical analytical-development environment.

• Demonstrated ability to independently execute and review complex analytical testing, interpret data, troubleshoot methods and instrumentation, and apply sound scientific judgment with minimal supervision.

• Proven involvement in analytical method validation, verification, or transfer; laboratory investigations; technical-document preparation; and the training or mentorship of less experienced laboratory personnel.

Education:

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a closely related chemistry-based scientific discipline required.

• Master’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field preferred.

Skills & Knowledge:

• Advanced proficiency with multiple analytical techniques, including HPLC, UPLC, GC, UV-Vis, dissolution, Karl Fischer titration, wet chemistry, and related pharmaceutical laboratory methods.

• Strong knowledge of analytical method validation, system suitability, chromatographic troubleshooting, scientific root-cause analysis, ICH Q2(R2), USP requirements, and applicable compendial procedures.

• Deep working knowledge of cGMP, GLP, 21 CFR Parts 11 and 211, ALCOA principles, Data Integrity expectations, OOS/OOT investigations, deviations, CAPAs, and laboratory change controls.

• Proficiency with chromatographic data systems and laboratory platforms such as Empower and LIMS, along with the ability to author protocols, technical reports, SOPs, test methods, and data summaries.

• Strong technical leadership, critical thinking, communication, organization, and mentoring skills with the ability to guide laboratory activities and cross-functional initiatives without formal supervisory authority.

What We Offer

• Competitive compensation with annual performance bonus eligibility

• Annual merit-based pay increases

• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed

• Paid Time Off

• 10 paid company holidays

• Comprehensive medical, dental, vision, and life insurance coverage

• Professional development reimbursement

• Career growth opportunities

• Tuition reimbursement for children and childcare expense reimbursement

Schedule

• Full-time, on-site position (Monday–Friday, 8:00 AM – 5:00 PM)

KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.