Senior Associate Manufacturing – Manufacturing Investigations
Amgen
Senior Associate Manufacturing – Manufacturing Investigations
Job Description
Career CategoryManufacturingJob DescriptionHOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Senior Associate Manufacturing – Manufacturing Investigations Live What you will do Let’s do this. Let’s change the world. 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 include: 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 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. Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The collaborative investigator we seek has a biologics Drug Substance manufacturing and microbiological investigations background with strong cross-functional project management and communication skills as well as the below qualifications. Basic Qualifications: High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience Or Associate’s Degree + 2 years manufacturing and/or other regulated environment experience Or Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience Or Master's Degree 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 Thrive What you can expect of us In addition to the base salary, 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 Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #AmgenNorthCarolina .Salary Range86,048.05USD -116,417.95 USD
Locations
- US - North Carolina - Holly Springs
Skills Required
- complianceintermediate
- Veeva QMS for Deviation investigationsintermediate
Required Qualifications
- High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience (experience, 4 years)
- High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience (experience, 4 years)
- Associate’s Degree + 2 years manufacturing and/or other regulated environment experience (experience, 2 years)
- Associate’s Degree + 2 years manufacturing and/or other regulated environment experience (experience, 2 years)
- Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience (experience)
- Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience (experience)
- Master's Degree (degree)
- Master's Degree (degree)
Preferred Qualifications
- 3+ years related work experience (manufacturing, microbiology, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility (experience, 3 years)
- 3+ years related work experience (manufacturing, microbiology, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility (experience, 3 years)
- Basic understanding of Drug Substance manufacturing, environmental monitoring programs, and contamination control principles. (experience)
- Basic understanding of Drug Substance manufacturing, environmental monitoring programs, and contamination control principles. (experience)
- Experience with compliance, problem-solving, simple and complex root cause analysis tools (5-whys, fishbone etc.) critical thinking, project management, and quality systems. (experience)
- Experience with compliance, problem-solving, simple and complex root cause analysis tools (5-whys, fishbone etc.) critical thinking, project management, and quality systems. (experience)
- Degree in Science or Engineering (Microbiology or similar a plus) (degree in science or engineering)
- Degree in Science or Engineering (Microbiology or similar a plus) (degree in science or engineering)
- Experience leading investigations (experience)
- Experience leading investigations (experience)
- Experience using Veeva QMS for Deviation investigations and CAPAs (experience)
- Experience using Veeva QMS for Deviation investigations and CAPAs (experience)
- Demonstrated project management ability (experience)
- Demonstrated project management ability (experience)
- Excellent written and verbal communication skills (experience)
- Excellent written and verbal communication skills (experience)
- Ability to work in a team matrix environment and build relationships with partners (experience)
- Ability to work in a team matrix environment and build relationships with partners (experience)
- Strong interpersonal skills (experience)
- Strong interpersonal skills (experience)
Responsibilities
- Let’s do this. Let’s change the world. 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.
- 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.
- 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.
- 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.
- 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.
- Present investigations to regulatory inspectors, internal auditors, and management.
- Clearly communicate investigation progress to impacted areas and leadership.
- Clearly communicate investigation progress to impacted areas and leadership.
- Coordinate and effectively lead cross-functional teams through investigations, and complete milestones on-schedule.
- 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.
- 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.
- Navigate through ambiguity and provide a structured problem-solving approach.
- Apply inductive and deductive reasoning in the investigation process
- Apply inductive and deductive reasoning in the investigation process
- Clear and concise technical writing
- Clear and concise technical writing
- Use Operational Learning Team strategies to promote open collaboration with staff to maximize investigation findings.
- 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.
- Develop tracking tools to ensure on-time closure and proactive review of deviation investigations.
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