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About the position
The Scientist II - QC is responsible for performing testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculating and reporting results on applicable specification documents, participating in method transfer activities within departments or between facilities or organizations. Provides feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture.
Responsibilities
- Performs chemical analysis of raw materials, in-process and finished pharmaceutical products, including products on stability, according to written methods or compendial methods as applicable, material specifications, using analytical techniques such as IR spectroscopy, UV-Vis spectroscopy, and chromatographic techniques, adhering to company policies as identified in standard operating procedures (SOPs).
- Prepares samples for analysis involving thorough cleanliness and complex steps for analysis using chromatographic techniques and analyzes.
- Creates and maintains laboratory record documentation (notebooks and computer-based), documents exact steps followed during analysis execution, calculates and reports results in a timely manner.
- Actively participates in method transfer activities between facilities within the organization or between organizations.
- Actively participates in and leads investigation of out-of-specification laboratory results, when required.
- Performs physical analysis involving complex techniques such as X-ray diffraction, DSC, Malvern mastersizer.
- Prepares and executes method transfer protocols, method verification/validation protocols as and when required.
