What are the responsibilities and job description for the Quality Control Chemist II position at Benuvia?
PURPOSE
Primary role is to perform chemical analysis of pharmaceutical products and routine laboratory operations in a cGMP environment.
Reports to the Quality Control Manager. Internal relationships include Manufacturing, Research & Development, Analytical Development and Quality Assurance.
DUTIES AND RESPONSIBILITIES :
- Conducts routine analysis of raw materials, in-process and finished Drug Substance and Drug Product according to Standard Operating Procedures (SOPs), cGMPs and cGLPs
- Conducts and reviews routine and non-routine analysis of raw materials, in-process materials, Drug Products (API), and Finished Drug Substances and Drug Products according to Standard Operating Procedures (SOPs), cGMPs and cGLPs
- Conducts testing using HPLC, GC, FTIR, UV-Vis and wet chemistry methods under supervision
- Compiles data for documentation of test procedures and prepares reports
- Calibrates and maintains lab equipment. Proactively ensure equipment is calibrated and maintained to minimize disruption to production schedules
- Administers quality control systems according to cGMP and FDA guidelines
- Write and Revise Standard Operating Procedures SOPs
- Ensures proper cGMP / cGLP documentation and maintenance of quality records.
- Participate in method validation and transfer activities.
QUALIFICATIONS (Education, Experience, Knowledge, and Skills) :
WORKING CONDITIONS / PHYSICAL REQUIREMENTS :
