Specialist Manufacturing Investigations

Amgen•Holly Springs, NC

7d•Onsite

About The Position

Amgen is seeking a Specialist-Manufacturing Investigations to join their team at the Amgen North Carolina Biologics Drug Substance Manufacturing plant. This role is crucial for investigating major deviations within the plant. The specialist will act as a liaison between GMP manufacturing teams and various stakeholder groups, including Process Development, Facilities & Engineering, Automation, EHS, and Quality. The position is responsible for ensuring that deviation investigations are conducted and documented effectively, while also driving improvements in the investigation process itself. This role is part of Amgen's commitment to sustainability and its plan to be a carbon-neutral company by 2027, with the FleX Batch facility integrating sustainability innovations.

Requirements

Doctorate degree OR Master’s degree & 2 years of directly related experience OR Bachelor’s degree & 4 years of directly related experience OR Associate’s degree & 8 years of directly related experience OR High school diploma / GED & 10 years of directly related experience

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.