QC Chemist II – Pharma Analytics & Methods

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, 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.