Sr Associate Mfg I- Investigations

About the role

In this vital role you will be a key member of the team that investigates major deviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and interface between the GMP manufacturing teams and stakeholder groups including Process Development, Facilities & Engineering, Automation, EHSS, and Quality. This position is responsible for ensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process.

Responsibilities

• Manage simple deviation and environmental monitoring investigations, specifically within the Controlled Environmental Monitoring space, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
• Apply a basic understanding of microbiology principles, environmental monitoring programs, and contamination control strategies to support environmental monitoring investigations.
• Interpret environmental monitoring data, identify trends, and assess potential impacts to product quality, manufacturing operations, and contamination control programs.
• Present investigations to regulatory inspectors, internal auditors, and management.
• Clearly communicate investigation progress to impacted areas and leadership.
• Coordinate and effectively lead cross-functional teams through investigations, and complete milestones on-schedule.
• Present investigation findings and technical information to diverse audiences and communicate moderately complex issues in a clear and concise manner.
• Build effective relationships across functions.
• Navigate through ambiguity and provide a structured problem-solving approach.
• Apply inductive and deductive reasoning in the investigation process.
• Use clear and concise technical writing.
• Use Operational Learning Team strategies to promote open collaboration with staff to maximize investigation findings.
• Develop tracking tools to ensure on-time closure and proactive review of deviation investigations.

Requirements

• Basic Qualifications:
  • Master’s degree
  • Or Bachelor’s degree & 6 months of directly related work experience
  • Or Associate’s degree & 2 years of directly related work experience
  • Or High school/GED & 4 years of directly related work experience
• Preferred Qualifications:
  • 3+ years related work experience (manufacturing, microbiology, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility.
  • Basic understanding of Drug Substance manufacturing, environmental monitoring programs, and contamination control principles.
  • Experience with compliance, problem-solving, simple and complex root cause analysis tools (5-whys, fishbone etc.), critical thinking, project management, and quality systems.
  • Degree in Science or Engineering (Microbiology or similar a plus).
  • Experience leading investigations.
  • Experience using Veeva QMS for Deviation investigations and CAPAs.
  • Demonstrated project management ability.
  • Excellent written and verbal communication skills.
  • Ability to work in a team matrix environment and build relationships with partners.
  • Strong interpersonal skills.

Benefits

• A comprehensive employee benefits package, including:
  • A Retirement and Savings Plan with generous company contributions
  • Group medical, dental, and vision coverage
  • Life and disability insurance
  • Flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.