Chemist II, Quality Control

Job Description

Job Description

JOB SUMMARY

The Chemist II, under minimal supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation. Has demonstrated competence in conducting all types of physical and chemical analyses (including complex analyses) using all equipment. Detects, conducts, and reports on OOS / OOT / NOE and other investigations. Learns and stays current with regulatory guidance and compendia relevant to laboratories and pharmaceutical manufacturing. Participates in troubleshooting analyses and instrumentation. Trains less senior staff.

All incumbents are responsible for following applicable Division & Company policies and procedures.

KEY ACCOUNTABILITIES

Analysis & Testing

• Conducts laboratory analyses according to approved test methods : finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. Typical activities may include buffer / solution preparation, standard preparation and operating analytical instruments : HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.
• Uses laboratory software for analyses
• Reviews and approves laboratory test data and documentation for completeness and compliance
• Is alert to and detects abnormalities during performances of tests and reviews. Elevates abnormalities to Supervisor
• Performs lab methods transfer and participate in method validation / verification studies

Lab Equipment

Investigations

Training

Compliance

Safety

QUALIFICATIONS

Education & Experience

Knowledge

Skills & Abilities