Senior QC Chemist - Lead Method Validation & Mentorship

KVK Tech, Inc.; Pennsylvania; On-site; USD 95,000 - 120,000; Full time

Benefits offered by this job

Annual bonus eligibility

Merit-based pay increases

401(k) with company match

Job summary

KVK Tech, Inc. is seeking a QC Chemist III to act as a senior analytical scientist in the Quality Control laboratory.

This role independently performs advanced testing, leads method validation and transfer activities, reviews data, and supports investigations while mentoring junior chemists and ensuring inspection readiness. The candidate will apply cGMP and data integrity principles, utilize Empower and LIMS, and provide cross-functional guidance to QA, Manufacturing, and Regulatory Affairs to

Qualifications

• Bachelor’s degree in Chemistry or Pharmaceutical Sciences required.
• Master’s degree in Chemistry, Analytical Chemistry, or a related field preferred.
• Demonstrated proficiency with analytical techniques and cGMP regulatory requirements.

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 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.

Skills

HPLC

UPLC

GC

UV-Vis

Dissolution

Karl Fischer titration

Wet chemistry

Method validation

Method transfer

Data interpretation

OOS/OOT investigations

Root-cause analysis

Empower

LIMS

cGMP compliance

Education

Bachelor’s degree in Chemistry or Pharmaceutical Sciences

Master’s degree in Chemistry or Analytical Chemistry

Tools

Empower

LIMS

Job description

KVK Tech, Inc. is seeking a QC Chemist III to act as a senior analytical scientist in the Quality Control laboratory.

This role independently performs advanced testing, leads method validation and transfer activities, reviews data, and supports investigations while mentoring junior chemists and ensuring inspection readiness. The candidate will apply cGMP and data integrity principles, utilize Empower and LIMS, and provide cross-functional guidance to QA, Manufacturing, and Regulatory Affairs to