Sr Associate Manufacturing Mfg. Investigations - Holly Springs, NC

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.
• Cookordinate 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.
• 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.

Qualifications

• High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience
• Associate’s Degree + 2 years manufacturing and/or other regulated environment experience
• Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience
• Master's Degree
• 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

Amgen offers a total rewards plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and 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 and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible