Senior Specialist – Complex Investigations
Amgen · Holly Springs, NC
The apply link worked recently (not employer-confirmed).
Role summary
This senior specialist role leads complex investigations at a biologics manufacturing facility in North Carolina, serving as the site expert for high-risk quality events and compliance issues. The position requires directing cross-functional teams through advanced root cause analysis, developing corrective actions, and identifying systemic improvement opportunities. The specialist provides technical guidance to investigators and presents findings to leadership and regulatory bodies.
What they're looking for
- Doctorate with 2 years related experience, or Master's with 4 years, or Bachelor's with 6 years, or equivalent
- Extensive experience leading complex investigations in regulated biotech or pharmaceutical settings
- Advanced root cause analysis methodologies and quality risk management expertise
- Strong understanding of GMP regulations, quality systems, deviation management, and regulatory expectations
- Demonstrated ability to influence cross-functional teams and senior leadership
- Exceptional technical writing and verbal communication skills
- Experience with Veeva QMS for investigations and CAPA management preferred
What you'll be doing
- Lead site's most complex cross-functional deviation and quality event investigations
- Assemble and lead investigation teams through root cause analysis and risk assessment activities
- Apply advanced methodologies including Kepner-Tregoe, Quality Risk Management, and data-driven problem solving
- Present investigation findings, risks, and recommendations to site leadership and governance teams
- Mentor investigators on investigation excellence, technical writing, and root cause analysis practices
Privacy & handoff
This role links to Amgen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.