QC Chemist III

KVK Tech, Inc.; Newtown Township (Delaware County); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

401(k) with company match

Health, vision, and dental Insurance

Annual merit increases

Paid Time Off and Flexible Holidays

Job summary

KVK Tech, Inc. seeks an accomplished QC Chemist III in Newtown, PA to serve as a senior analytical scientist in the Quality Control lab supporting oral solid dosage manufacturing.

The role independently performs advanced testing (HPLC/UPLC/GC/UV-Vis), leads method validation and transfers, troubleshoots complex issues, reviews data, and mentors junior chemists while ensuring Data Integrity and regulatory compliance.

Qualifications

• Bachelor’s degree in Chemistry or related field required; Master’s preferred.
• 6+ years of progressive analytical lab experience in a cGMP pharma QC/analytical-development environment.
• Advanced proficiency with HPLC and complementary techniques (UPLC, GC, UV-Vis, dissolution, Karl Fischer).
• Experience leading/performing method validation, verification, and transfer and solving instrument issues.
• Experience reviewing GMP analytical data and supporting investigations, CAPAs, and change controls.
• Strong knowledge of cGMP, GLP, ICH Q2(R2), USP, 21 CFR Parts 11 and 211; data integrity expectations.

Responsibilities

• Perform and oversee advanced analytical testing using HPLC, UPLC, GC, UV-Vis, dissolution, Karl Fischer titration, and other validated methods.
• Lead or execute analytical method validation, verification, and transfer activities with proper documentation.
• Evaluate complex analytical results, identify trends, and support OOS/OOT investigations and CAPAs.
• Review and approve laboratory data, calculations, and chromatographic results for accuracy and data integrity.
• Qualify, calibrate, and maintain laboratory instrumentation; author protocols and SOPs.
• Provide technical guidance and mentorship to junior chemists and support cross-functional problem-solving.

Skills

Analytical leadership

Mentoring

Regulatory knowledge

Data Integrity

Scientific writing

Communication

Education

Bachelor’s degree in Chemistry

Master’s degree in Chemistry or Analytical Chemistry

Tools

HPLC

UPLC

GC

UV-Vis

Dissolution

Karl Fischer titration

Empower

LIMS

Job description

KVK Tech is seeking an accomplished QC Chemist III to join our team in Newtown, PA.

The QC Chemist III will serve as a senior analytical scientist and technical resource within the Quality Control laboratory supporting oral solid dosage pharmaceutical manufacturing. 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 ideal candidate will demonstrate advanced analytical expertise, strong regulatory knowledge, and the ability to provide technical leadership and mentorship while operating as a senior individual contributor without formal personnel-management responsibilities.

This position’s responsibilities will include, but not be limited to the following:

• Perform and oversee advanced analytical testing using HPLC, UPLC, GC, UV-Vis, dissolution, Karl Fischer titration, wet chemistry, and other validated, compendial, or internal methods.


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


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


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


• Provide technical guidance, training, and mentorship to junior chemists while supporting cross-functional problem-solving, laboratory improvements, and regulatory inspection readiness.

We are looking for applicants with:

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


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


• Advanced independent proficiency with HPLC and multiple additional techniques such as UPLC, GC, UV-Vis, dissolution, Karl Fischer titration, and wet chemistry.


• Proven experience leading or independently executing analytical method validation, verification, or transfer and resolving complex method or instrument-related problems.


• Demonstrated experience reviewing GMP analytical data and supporting OOS/OOT investigations, scientific root-cause analysis, deviations, CAPAs, and laboratory change controls.


• Deep working knowledge of cGMP, GLP, ICH Q2(R2), USP requirements, 21 CFR Parts 11 and 211, ALCOA principles, system suitability, and Data Integrity expectations.


• Strong technical leadership, scientific writing, critical thinking, communication, and mentoring skills with proficiency in Empower, LIMS, and electronic laboratory systems.

What we offer:

• 401(k) with company match


• Health, vision, and dental Insurance


• 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.

All KVK Tech products are made in the USA in strictest accordance with FDA, DEA, and DEP guidelines.