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QC Analytical Scientist
4 months ago
POSITION SUMMARY:
The Sr Quality Control Associate will be responsible for performing multiple tasks within the Quality Control (QC) group in support of GMP large–molecule manufacturing activities. Focus areas include execution of analytical method qualification/validation protocols, routine analytical testing and documentation/data review of QC generated results. The position requires extensive experience within a QC setting and detailed knowledge of GMP/GDP. The associate will perform a variety of responsibilities in both a team and individual setting. This position is an on–site position.
POSITION RESPONSIBILITIES:
Provides review and approval of analytical test method qualification/validation protocols received from Analytical Technologies (AT) and external method development laboratories.
Leads the execution of qualification/validation protocols and writes technical reports in collaboration with Analytical Technologies (AT).
Leads the implementation of programs (e.g. evaluation/implementation of compendial testing).
Participate in/Support cross–functional projects and teams as a Subject Matter Expert (SME).
Demonstrates a working knowledge of compendia testing (USP, Ph. EUR, JP, etc.) wet chemistry techniques and analytical analysis (U/HPLC, GC, FTIR, KF, etc.)
Leads laboratory investigations to determine root cause for OOS, OOT, Atypical and invalid test results.
Contributes to laboratory operations by performing regular instrument calibration and minor instrument maintenance.
Support operational systems (e.g. equipment maintenance, reagent preparation, forms control, etc.).
