Senior QC Chemist - GMP Analytics & Instrumentation

Merck & Co.

Durham (NC)

On-site

USD 65,000 - 75,000

Full time

14 days+

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Benefits offered by this job

Medical plans
Dental benefits
Vision plan
Life Insurance
Disability Insurance
401(k) plan

Job summary

Aurolife, a Merck-affiliated pharmaceutical division, seeks a Chemist B to ensure products and materials meet quality standards by performing analytical tests and maintaining documentation. This role requires strong attention to detail, GMP compliance, and ability to work in regulated environments.

The position involves testing raw materials, APIs, in-process and finished goods using methods like HPLC, GC, UV-Vis, and IR, with responsibilities spanning SOPs, calibration, documentation, and

Qualifications

  • BS in Chemistry or related scientific field.
  • 3–5 years experience in pharmaceuticals with 2–4 years in analytical testing.
  • Knowledge of USP/ICH/FDA regulations and Good Documentation practices.

Responsibilities

  • Perform physical, chemical and instrumental tests on raw materials, APIs, in-process, finished and stability products using wet chemicals and instrumental techniques per USP/In-house/any other Compendial monographs.
  • Independently plan and inventory test reagents and solutions to ensure supplies.
  • Plan and execute testing to meet established timelines; perform complex tests with supervisory direction.
  • Record data and results as specified in documentation procedures; document work clearly.
  • Prepare and/or review Test Procedures, SOPs, and Protocols as assigned.
  • Perform maintenance and calibrations of laboratory instruments with supervisory direction.
  • Troubleshoot and investigate under supervision.
  • Comply with regulatory/in-house requirements (safety, housekeeping, waste, cGMP, cGLP, documentation).
  • Review Analytical documents as required.

Skills

Pharmaceutical experience
Analytical testing
Documentation practices
Regulatory knowledge
Decision making

Education

BS in Chemistry

Tools

HPLC
GC
UV-Vis
IR
KF Auto titrator
Particle Size Analyzer

Job description

Aurolife, a Merck-affiliated pharmaceutical division, seeks a Chemist B to ensure products and materials meet quality standards by performing analytical tests and maintaining documentation. This role requires strong attention to detail, GMP compliance, and ability to work in regulated environments.

The position involves testing raw materials, APIs, in-process and finished goods using methods like HPLC, GC, UV-Vis, and IR, with responsibilities spanning SOPs, calibration, documentation, and

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