Senior QC Chemist: Stability & In-Process Testing

Merck & Co.; Durham (NC); On-site; USD 80,000 - 89,000; Full time

Benefits offered by this job

Medical and Rx Benefits

Dental Benefits

Vision Plan

Life Insurance

Disability Insurance

401(k) Plan

Job summary

Aurolife seeks a QC Chemist C to join the stability team, performing bench‑level analytical tests and reviewing documentation to ensure GLP status. Responsibilities include in‑process, finished product and stability testing with HPLC, GC, UV‑Vis, IR, and related methods.

The role requires 5+ years in pharma analytics, knowledge of USP/ICH/FDA guidelines, and flexibility to meet deliverables in a regulated environment. On-site position with comprehensive benefits.

Qualifications

• Minimum 5+ years of experience in Pharmaceuticals and Analytical testing.
• Preference shall be given for experience in Inhalation testing on various products.
• Experience in a cGMP environment is required.
• Knowledge of Good Documentation practices.
• Knowledge of USP/ICH/FDA guidelines.

Responsibilities

• Perform in-process, finished product and stability testing using wet chemicals and instrumental techniques (HPLC, UPLC, GC, UV-Vis, IR, etc.).
• Plan and execute testing to meet established timelines.
• Assist with preparation or review of Test Procedures, SOPs, Protocols, and CoAs.
• Record data and results per documentation procedures; audit data integrity.
• Maintain calibration and upkeep of laboratory instruments.
• Troubleshoot investigations under supervisor guidance.
• Assist in drafting deviation reports.
• Ensure compliance with safety, cGMP, cGLP, and documentation requirements.
• Review analytical documents and investigate OOS/OOT/Deviations.

Skills

EMPOWER Chromatography Data System

LIMS

cGMP environment

Good Documentation practices

USP/ICH/FDA guidelines

Team player

Flexibility in hours

Quick learner

Education

BS/MS in Chemistry or Pharmaceutical Sciences

Tools

EMPOWER CDS

LIMS

Job description

Aurolife seeks a QC Chemist C to join the stability team, performing bench‑level analytical tests and reviewing documentation to ensure GLP status. Responsibilities include in‑process, finished product and stability testing with HPLC, GC, UV‑Vis, IR, and related methods.

The role requires 5+ years in pharma analytics, knowledge of USP/ICH/FDA guidelines, and flexibility to meet deliverables in a regulated environment. On-site position with comprehensive benefits.