QC Chemist II

About the role

KVK Tech is seeking an experienced QC Chemist II to join our team in Newtown, PA. The QC Chemist II will independently perform complex analytical testing of raw materials, in-process materials, finished products, and stability samples within an oral solid dosage pharmaceutical manufacturing environment. This role applies scientific judgment to analytical data evaluation, instrument troubleshooting, laboratory investigations, data review, and method verification, validation, and transfer activities.

Responsibilities

• Perform routine and complex analytical testing using HPLC, UPLC, GC, UV-Vis, dissolution, Karl Fischer titration, wet chemistry, and other approved analytical techniques.
• Independently evaluate analytical data for conformance to specifications, identify atypical results or trends, and promptly escalate potential OOS/OOT findings.
• Execute assigned method verification, validation, and transfer activities while generating accurate supporting data, calculations, and technical documentation.
• Review peer-generated analytical data and laboratory records for accuracy, completeness, scientific validity, and compliance before supervisory review.
• Maintain, calibrate, and troubleshoot analytical instrumentation while performing preventive maintenance, readiness checks, and minor repairs within established procedures.
• Support laboratory investigations, deviations, root-cause analysis, CAPA implementation, change controls, method optimization, and technical guidance of less-experienced chemists.

Requirements

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a closely related chemistry-based scientific discipline required; Master’s degree in Chemistry or Analytical Science preferred.
• Minimum 3-6 years of progressively responsible experience in a cGMP-regulated pharmaceutical analytical or Quality Control laboratory.
• Demonstrated independent proficiency with HPLC and multiple additional analytical techniques such as UPLC, GC, UV-Vis, dissolution, Karl Fischer titration, or wet chemistry.
• Experience interpreting complex analytical data, reviewing laboratory documentation, troubleshooting instrumentation, and applying scientific judgment with limited supervision.
• Practical experience supporting method verification, validation, or transfer and contributing to OOS/OOT investigations, deviations, CAPAs, or laboratory change controls.
• Strong working knowledge of cGMP, GLP, 21 CFR Parts 11 and 211, ALCOA principles, Data Integrity requirements, and applicable USP or compendial procedures.
• Proficiency with Empower, LIMS, Microsoft Excel, and laboratory documentation systems, with strong technical writing, organizational, and communication skills.

Benefits

• 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