QC Chemist I
KVK Tech is seeking a detail-oriented QC Chemist I to join our team in Newtown, PA.
The QC Chemist I will perform routine analytical testing of raw materials, in-process materials, finished products, and stability samples in support of oral solid dosage pharmaceutical manufacturing. This role independently executes assigned methods after qualification, operates commonly used laboratory instrumentation, and generates accurate, contemporaneous data in accordance with cGMP and Data Integrity requirements. The ideal candidate will demonstrate hands-on analytical laboratory proficiency, sound foundational scientific judgment, and the ability to perform routine testing accurately while escalating atypical results or technical concerns appropriately.
This position’s responsibilities will include, but not be limited to the following:
- Perform routine chemical and physical analyses using approved, validated, compendial, or internal test methods after completing required training and qualification.
- Operate analytical instrumentation including HPLC, UV-Vis, dissolution equipment, Karl Fischer titrators, pH meters, balances, and related laboratory equipment.
- Prepare samples, standards, reference solutions, reagents, buffers, and mobile phases accurately and in accordance with approved procedures.
- Document and review personal laboratory work for accuracy, completeness, calculation correctness, and compliance with cGMP, ALCOA, and Data Integrity requirements.
- Perform assigned instrument calibrations, preventive maintenance, readiness checks, and basic troubleshooting while promptly escalating equipment or method concerns.
- Support OOS/OOT investigations, method transfers, validation activities, sample handling, laboratory housekeeping, and other departmental quality objectives as assigned.
We are looking for applicants with:
- Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a closely related chemistry-based scientific discipline required.
- 1-3 years of relevant professional analytical laboratory experience; candidates with a Master’s degree specifically in Chemistry and no professional experience may also be considered.
- Hands-on experience or substantive academic training with HPLC and additional techniques such as UV-Vis, dissolution, Karl Fischer titration, pH measurement, titration, or wet chemistry.
- Ability to independently perform routine analytical testing after qualification, prepare standards and samples, complete scientific calculations, and evaluate results against established criteria.
- Foundational working knowledge of cGMP, GLP, ALCOA principles, Data Integrity expectations, and accurate contemporaneous laboratory documentation.
- Strong attention to detail, scientific judgment, organization, and ability to recognize and escalate atypical results, potential OOS/OOT events, or equipment concerns.
- Proficiency with Microsoft Office applications and familiarity with chromatographic data systems or laboratory platforms such as Empower and LIMS preferred.
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.
