Duties:
Primary responsibilities for this position include performing tasks associated with release testing and reviewing laboratory data. The analyst will be responsible for ensuring that samples are collected, tested, and reviewed according to quality requirements and results reported are valid, accurate, and documented per applicable regulatory and corporate requirements. Analyst may be required to perform or participate in tasks associated with method verification.
Major Accountabilities:
Perform Sterility, Endotoxin, Growth Promotion, Biological Indicator and Bioburden testing
Assist with assay trouble shooting
Maintain compliance with applicable cGMP requirements
Ensure thorough analysis of testing failures
Performs shift-work as necessary to support manufacturing (some weekend work required)
Experience with LIMS preferred
Skills:
BS degree in science with 2 to 3 years directly related laboratory experience or equivalent education experience combination.
Knowledge of USP/EP Compendia
Education:
Bachelor's degree in Scientific discipline and 3+ years' experience or associate's and 5+ years of industry experience or equivalent
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Last updated on Dec 20, 2016