Posted 21 hours ago
Senior Associate Manufacturing Deviation Owner Environmental and Contamination Control
Amgen
Requirements
High school diploma + 4 years manufacturing experience, Associate’s degree + 2 years manufacturing experience, Bachelor’s degree + 6 months manufacturing experience, Master’s degree, Technical writing skills, Root cause analysis expertise
Skills
Root Cause AnalysisCAPAQuality Management System
About the role
Responsibilities
- Manage end-to-end deviation records, including investigation, documentation, and resolution to ensure regulatory compliance.
- Act as a technical writer to articulate complex manufacturing events into clear, inspection-ready documentation.
- Define and execute investigation strategies, including shopfloor observations, Gemba activities, and interviews.
- Conduct root cause analyses (RCA) and ensure scientific justification for all conclusions.
- Lead CAPA identification and development aligned with investigation outcomes.
- Coordinate with cross-functional teams including Quality Assurance, QC, Process Development, and Engineering.
- Serve as a Subject Matter Expert (SME) during regulatory inspections to defend investigation rationale.
- Provide data analysis for deviation trending and identify opportunities for contamination control improvements.
Requirements
- High school diploma / GED and 4 years of manufacturing and/or operations experience
- Associate’s degree and 2 years of manufacturing and/or operations experience
- Bachelor’s degree and 6 months of manufacturing and/or operations experience
- Master’s degree
- Strong technical writing skills and expertise in root cause analysis
Preferred Qualifications
- BS/BA in science, engineering, or psychology
- 2+ years of experience in the pharmaceutical industry
- Experience applying AI or other digital tools to generate insights and streamline workflows
Benefits
- Comprehensive medical, dental, and vision coverage
- Retirement and Savings Plan with generous company contributions
- Discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
About the Company
Amgen is a leading biotechnology company dedicated to discovering, developing, and manufacturing innovative human therapeutics. Since 1980, Amgen has focused on serving patients living with serious illnesses in therapeutic areas such as Oncology, Inflammation, General Medicine, and Rare Disease.
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Amgen · West Greenwich
