Specialist - Manufacturing Investigations
Amgen
14 days ago
On-site
Holly Springs, NC
Operations
Specialist - Manufacturing Investigations
What You Will Do
Responsibilities include:
- Manage major deviation investigations: assemble teams, lead root cause analysis, develop CAPAs, and ensure compliant documentation.
- Drive improvements to the investigation process.
- Present investigations to regulatory inspectors, internal auditors, and management.
- Communicate investigation progress to impacted areas and leadership.
- Lead cross-functional teams to complete milestones on-schedule.
- Present complex topics to large/small groups; clearly communicate issues.
- Build cross-functional relationships; use a structured problem-solving approach amid ambiguity.
- Apply inductive/deductive reasoning; clear, concise technical writing.
- Use Operational Learning Team strategies to improve collaboration.
- Develop tracking tools for on-time closure and proactive review.
What We Expect Of You
Basic Qualifications (one):
- Doctorate degree OR
- Master’s in chemistry/biology/engineering + 3 years biotechnology operations OR
- Bachelor’s + 5 years biotechnology operations OR
- Associate’s + 10 years biotechnology operations OR
- High school/GED + 12 years biotechnology operations
Preferred Qualifications:
- 5+ years in biotech/pharma manufacturing, process development, or QA with increasing responsibility
- Compliance knowledge; root-cause tools (e.g., 5-Whys, fishbone, Kepner-Tregoe, DOE); critical thinking; quality systems
- Degree in Science or Engineering; led complex investigations
- Veeva QMS experience for deviations/CAPAs; project management ability
- Presented to inspectors/audits; excellent written/verbal communication
- Team-matrix collaboration; strong interpersonal skills
What You Can Expect Of Us (Benefits)
- Comprehensive employee benefits (retirement/savings, medical/dental/vision, life/disability, flexible spending), discretionary bonus, stock-based long-term incentives, time-off plans, flexible work where possible.
Apply now: careers.amgen.com
What You Will Do
Responsibilities include:
- Manage major deviation investigations: assemble teams, lead root cause analysis, develop CAPAs, and ensure compliant documentation.
- Drive improvements to the investigation process.
- Present investigations to regulatory inspectors, internal auditors, and management.
- Communicate investigation progress to impacted areas and leadership.
- Lead cross-functional teams to complete milestones on-schedule.
- Present complex topics to large/small groups; clearly communicate issues.
- Build cross-functional relationships; use a structured problem-solving approach amid ambiguity.
- Apply inductive/deductive reasoning; clear, concise technical writing.
- Use Operational Learning Team strategies to improve collaboration.
- Develop tracking tools for on-time closure and proactive review.
What We Expect Of You
Basic Qualifications (one):
- Doctorate degree OR
- Master’s in chemistry/biology/engineering + 3 years biotechnology operations OR
- Bachelor’s + 5 years biotechnology operations OR
- Associate’s + 10 years biotechnology operations OR
- High school/GED + 12 years biotechnology operations
Preferred Qualifications:
- 5+ years in biotech/pharma manufacturing, process development, or QA with increasing responsibility
- Compliance knowledge; root-cause tools (e.g., 5-Whys, fishbone, Kepner-Tregoe, DOE); critical thinking; quality systems
- Degree in Science or Engineering; led complex investigations
- Veeva QMS experience for deviations/CAPAs; project management ability
- Presented to inspectors/audits; excellent written/verbal communication
- Team-matrix collaboration; strong interpersonal skills
What You Can Expect Of Us (Benefits)
- Comprehensive employee benefits (retirement/savings, medical/dental/vision, life/disability, flexible spending), discretionary bonus, stock-based long-term incentives, time-off plans, flexible work where possible.
Apply now: careers.amgen.com