Overview
Specialist – Manufacturing Investigations Jobs in Holly Springs, USA at BioSpace
Overview
HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. 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, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Be part of Amgen’s newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleXBatch facility will combine disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleXBatch facility will feature best-in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities and will integrate sustainability innovations as part of Amgen’s plan to be a carbon-neutral company by 2027.
Position
Specialist – Manufacturing Investigations
What You Will Do
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 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 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 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 qualifications below.
Basic Qualifications
- Doctorate degree OR
- Masters degree in chemistry, biology, or engineering & 3 years of biotechnology operations experience OR
- Bachelors degree and 5 years of biotechnology operations experience OR
- Associates degree & 10 years of biotechnology operations experience OR
- High school diploma / GED & 12 years of biotechnology operations experience
Preferred Qualifications
- 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-Trego 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
Thrive
What You Can Expect From Us
As we work…
Title: Specialist – Manufacturing Investigations
Company: BioSpace
Location: Holly Springs, USA
Category:
