About the role

  • 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)

Benefits

  • Eligibility for bonus
  • Stock options
  • Health insurance
  • Professional development opportunities

Job title

Manufacturing Operations Investigator

Job type

Experience level

Mid levelSenior

Salary

$74,560 - $116,500 per year

Degree requirement

Bachelor's Degree

Location requirements

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