QC Chemist I

Job Description

Job Description

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 I is responsible for performing routine analytical testing in support of raw material, in-process, finished product, packaging component, and stability sample evaluation within a cGMP-regulated pharmaceutical laboratory. This role generates accurate, ALCOA-compliant data to support product quality and release while operating analytical instrumentation and executing approved methods in accordance with compendial requirements, internal procedures, and regulatory expectations. The QC Chemist I also supports laboratory readiness, documentation accuracy, and overall compliance with safety and quality standards.

Key Responsibilities:
• Perform routine analytical testing of raw materials, in-process samples, finished products, packaging components, and stability samples using approved methods and compendial procedures.
• Operate and support analytical instrumentation including HPLC, UV-Vis, dissolution equipment, pH meters, balances, and titration systems.
• Prepare standards, reagents, solutions, and mobile phases in accordance with approved procedures and laboratory safety requirements.
• Document all testing activities, calculations, and results accurately and contemporaneously in compliance with cGMP, Data Integrity, and ALCOA principles.
• Review analytical results against established specifications and promptly escalate OOS, OOT, or atypical findings to laboratory supervision.
• Perform routine equipment calibration, maintenance, and basic troubleshooting to support laboratory operational readiness.
• Maintain laboratory housekeeping, sample management, and chemical handling practices in compliance with SOPs, OSHA, EPA, and company safety standards.

What We’re Looking For

Experience:
• 1-3 years of experience in a pharmaceutical, analytical, or other regulated laboratory environment preferred.
• Exposure to cGMP documentation practices, laboratory instrumentation, and analytical testing principles is preferred.

Education:
• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a closely related scientific discipline required.

Skills & Knowledge:
• Foundational understanding of analytical techniques such as HPLC, UV-Vis, dissolution, titration, and pH testing.
• Basic knowledge of cGMP, GLP, Good Documentation Practices, and Data Integrity expectations.
• Strong attention to detail and ability to maintain accurate, complete, and contemporaneous laboratory documentation.
• Ability to interpret analytical data and apply sound scientific judgment under supervision.
• Effective written and verbal communication skills with the ability to follow detailed procedures and instructions.
• Proficiency in Microsoft Office; familiarity with LIMS or other laboratory systems preferred.
• Commitment to laboratory safety, compliance, and continuous learning in a regulated pharmaceutical environment.

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)

\nCompany Description

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.

Company Description

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.