Sr Associate Mfg I- Investigations

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Associate Manufacturing I – Investigations
 

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.

• 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.
   

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

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