Biotech Manufacturing Investigations Specialist

Amgen SA; Holly Springs (NC); Hybrid; USD 110.000 - 160.000; Vollzeit

Benefits dieser Stelle

Total Rewards Plan

Flexible work models

Medical, dental, vision coverage

Retirement plan

Stock-based incentives

Time-off programs

Zusammenfassung

Amgen North Carolina is seeking a Specialist-Manufacturing Investigations to join the biologics operations team. You will investigate major deviations in the NC Biologics Drug Substance plant, interfacing with GMP manufacturing, Process Development, Facilities & Engineering, Automation, EHSS, and Quality to ensure investigations are thorough and well-documented.

The role requires extensive root-cause analysis, project management, and strong technical writing, with opportunities to present

Qualifikationen

• Biologics Drug Substance manufacturing and investigations background.
• Experience with compliance, problem-solving, root cause analysis tools.
• Experience presenting to inspectors during regulatory inspections.

Aufgaben

• Manage major deviation investigations, assemble teams, lead root cause analysis, develop CAPAs.
• Drive improvements to the investigation process and timing.
• Present investigations to regulatory inspectors, internal auditors, and management.
• Communicate progress to leadership and impacted areas.
• Lead cross-functional teams through complex investigations and meet milestones.
• Communicate complex topics clearly to varied audiences.
• Build relationships across functions and navigate ambiguity.
• Apply inductive and deductive reasoning; write concise technical documents.
• Develop tools to track on-time closure and proactive review of investigations.

Kenntnisse

Biologics manufacturing

Root cause analysis

Project management

Cross-functional collaboration

Regulatory inspection experience

Technical writing

Communication skills

Teamwork in matrix environment

Ausbildung

Doctorate degree

Master’s degree + 3 yrs related experience

Bachelor’s degree + 5 yrs related experience

Associate’s degree + 10 yrs related experience

High school diploma + 12 yrs related experience

Tools

Veeva QMS

CAPA tools

Jobbeschreibung

Amgen North Carolina is seeking a Specialist-Manufacturing Investigations to join the biologics operations team. You will investigate major deviations in the NC Biologics Drug Substance plant, interfacing with GMP manufacturing, Process Development, Facilities & Engineering, Automation, EHSS, and Quality to ensure investigations are thorough and well-documented.

The role requires extensive root-cause analysis, project management, and strong technical writing, with opportunities to present