Quality Control Chemistry

Description: Quality Control Chemistry is responsible for testing intermediate and final product samples to demonstrate that all products meet all standards required for cGMP operations. Various techniques are utilized in Quality Control including FT-IR, UV, KF, HPLC and GC. Additional functions include daily calibration, stability testing, assay transfers etc. in the Quality Control laboratory.

JOB RESPONSIBILITIES

§ The QC Analyst is responsible for performing routine to complex techniques

associated with daily QC release and provides an investigative or technological

orientation in implementing, executing, and interpreting quality procedures and

test methods.

§ Perform UV-Vis spectrophotometry, HPLC and Gel assays for in-process and final

product samples.

§ Perform pH, karl Fischer, Osmolarity, Rheology analysis in accordance with

approved procedure.

§ Perform maintenance on complex laboratory equipment including HPLC and GC

systems.

§ Investigate and troubleshoot Quality Control methods.

§ Prepare investigations related to 00S/00T results.

§ Review QC Data for compliance to procedures and specifications.

§ Prepare statistical analysis of results.

§ Identify deviations from QC methods.

§ Recommend method improvements.

§ Work effectively with others to achieve shared goals.

§ Interact with external personnel on technical matters requiring coordination

between sites.

§ Work independently with minimal supervision and direction.

§ Work in compliance with cGMPs.

§ Practice safe work habits and adhere to Sanofi's safety procedures and guidelines
Basic Qualifications

Bachelor's Degree in Life Sciences discipline and 2 years' experience in cGMP lab environment, or a
Master's Degree in Life Sciences discipline and 1 years' experience in cGMP lab environment.
Proficient in Outlook and Microsoft Word and Excel and lab-based data management systems
Scientific technical writing ability.

Preferred Qualifications
Experience with pH, KF, FT-IR, GC, HPLC, Gel, UV Vis Spectroscopy and wet chemistry.
Experience with Empower software.
Knowledge of lab-based data management systems.
Familiarity with USP and global compendia requirements.
Scientific technical writing ability.