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Senior Quality Control Analytical Scientist
2 months ago
The Senior Quality Control Analytical Scientist will be tasked with a variety of responsibilities within the Quality Control (QC) department, specifically in support of GMP large-molecule production processes.
This role emphasizes the execution of analytical method qualification and validation protocols, alongside routine analytical assessments and the review of documentation and data generated by QC activities. A robust background in a QC environment and a comprehensive understanding of GMP/GDP regulations are essential. The role will involve both collaborative and independent work settings, and it is an on-site position.POSITION RESPONSIBILITIES:
Oversee the review and endorsement of analytical test method qualification and validation protocols from Analytical Technologies (AT) and external laboratories specializing in method development.
Lead the execution of qualification and validation protocols, drafting technical reports in partnership with Analytical Technologies (AT).Facilitate the implementation of programs, including the evaluation and adoption of compendial testing methodologies.
Engage in and support cross-functional initiatives and teams as a Subject Matter Expert (SME).
Exhibit a solid understanding of compendial testing (USP, Ph. EUR, JP, etc.), wet chemistry techniques, and analytical methodologies (U/HPLC, GC, FTIR, KF, etc.).
Direct laboratory investigations to ascertain root causes for Out of Specification (OOS), Out of Trend (OOT), atypical, and invalid test results.
Enhance laboratory operations by conducting routine instrument calibrations and performing minor maintenance on equipment.
Assist in the management of operational systems, including equipment upkeep, reagent preparation, and forms control.
