QC Chemist II

KVK Tech, Inc.; Newtown Township (Delaware County); On-site; USD 70,000 - 90,000; 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. is seeking an experienced QC Chemist II to join our team in Newtown, PA.

The role performs complex analytical testing of raw materials, in-process materials, finished products, and stability samples in an oral solid dosage pharmaceutical environment. The ideal candidate will have hands-on proficiency with HPLC, UPLC, GC, UV-Vis, dissolution, and Karl Fischer titration, along with solid cGMP knowledge and data integrity experience.

Qualifications

• Bachelor’s degree in Chemistry or related field required.
• 3–6 years in a cGMP-regulated pharma analytical lab.
• Proficiency with HPLC and additional analytical techniques.
• Ability to interpret data, review docs, troubleshoot instrumentation.
• Experience with method verification/validation/transfer.
• Strong knowledge of cGMP, GLP, 21 CFR Part 11/211.
• Proficiency with Empower, LIMS, Excel and modern lab systems.

Responsibilities

• Perform routine and complex analytical testing using HPLC, UPLC, GC, UV-Vis, dissolution, and Karl Fischer titration.
• Evaluate analytical data against specifications and investigate OOS/OOT findings.
• Execute method verification, validation, and transfer activities with proper documentation.
• Review peer data and lab records for accuracy and compliance.
• Maintain and troubleshoot instrumentation and perform preventive maintenance.
• Support investigations, CAPAs, deviations, and change controls.

Skills

HPLC

UPLC

GC

UV-Vis

Dissolution

Karl Fischer

Data review

cGMP knowledge

Instrument troubleshooting

Empower

LIMS

Excel

Technical writing

Education

Bachelor’s degree in Chemistry

Master’s degree preferred

Tools

Empower

LIMS

Job description

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. The ideal candidate will demonstrate strong hands‑on proficiency with pharmaceutical analytical instrumentation, practical cGMP knowledge, and the ability to manage technically complex assignments with limited supervision.

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

• 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 elevate 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.

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 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.

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.