Specialist-Manufacturing Investigations

Amgen

About The Position

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. 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. 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. Specialist-Manufacturing 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 Major deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings. Drive improvements to the investigation process. 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 complex investigations, and complete milestones on-schedule. Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues. 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 collaborative investigator we seek has a biologics Drug Substance manufacturing and investigations background with strong cross-functional project management and communication skills as well as the below qualifications.

Requirements

High school diploma / GED and 10 years of Quality Control experience OR Associate’s degree and 8 years of Quality Control experience OR Bachelor’s degree and 4 years of Quality Control experience OR Master’s degree and 2 years of Quality Control experience OR Doctorate degree

Nice To Haves

5+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
Experience with compliance, problem-solving, simple and complex root cause analysis tools (5-whys, fishbone, Kepner Tregoe Problem Analysis®, Design of Experiment etc.) critical thinking, project management, and quality systems.
Degree in Science or Engineering
Experience leading complex investigations
Experience using Veeva QMS for Deviation investigations and CAPAs
Demonstrated project management ability
Experience presenting to inspectors during regulatory inspections and internal audits.
Excellent written and verbal communication skills
Ability to work in a team matrix environment and build relationships with partners
Strong interpersonal skills

Responsibilities

Manage Major deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
Drive improvements to the investigation process.
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 complex investigations, and complete milestones on-schedule.
Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
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.