Manufacturing Operations Investigator improving biopharmaceutical production processes through investigations and CAPA plans. Collaborating with teams and authoring reports in a high-performance environment.
Responsibilities
Perform manufacturing investigations, including deviations, environmental excursions, nonconformances, discrepancies to improve manufacturing processes
Collaborate with cross-functional teams to develop effective Corrective and Preventative Action (CAPA) plans
Author comprehensive investigation reports
Analyze process data and evaluate trends to identify continuous process improvement opportunities
Requirements
Bachelor’s degree in a science-related field or equivalent
3+ years related experience and/or training in a GMP Production Environment applying Root Cause Analysis techniques
Strong understanding of GMP guidelines and international regulations for API and drug production
Experience with root cause analysis, technical writing, and SOP development
Skilled utilizing Microsoft products (Word, Excel and Visio preferred)
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