Senior Associate, Manufacturing Investigations (Remote)

BioSpace; Holly Springs (NC); Hybrid; USD 85,000 - 120,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Flexible work models

Stock-based long-term incentives

Job summary

Amgen is seeking a Senior Associate for Manufacturing Investigations at the FleXbatch site in North Carolina. You will manage environmental monitoring investigations, perform root cause analysis, and develop CAPAs to ensure product quality and compliance.

The role requires collaboration across cross-functional teams and effective communication with regulators and management. The position offers exposure to state-of-the-art manufacturing technologies, industry 4.0 capabilities, and a

Qualifications

• High School Diploma/GED with 4+ years in manufacturing or regulated environments
• Associate’s Degree with 2+ years in manufacturing or regulated environments
• Bachelor’s Degree with 6 months+ in manufacturing or regulated environments
• Master’s Degree in a related field
• Experience leading investigations
• Experience with Veeva QMS for Deviation investigations and CAPAs

Responsibilities

• Manage deviation and environmental monitoring investigations within the Controlled Environmental Monitoring space
• Lead root cause analysis and development of CAPAs
• Interpret environmental monitoring data and assess impact on product quality
• Present investigations to regulators and internal auditors
• Communicate investigation progress to impacted areas and leadership
• Coordinate cross-functional teams to complete milestones on schedule
• Prepare and present findings in clear, concise technical writing
• Develop tracking tools to ensure on-time closure of investigations

Skills

Investigations

Cross-functional collaboration

Communication skills

Problem solving

Education

High School Diploma/GED

Associate’s Degree

Bachelor’s Degree

Master’s Degree

Tools

Veeva QMS

Job description

Amgen is seeking a Senior Associate for Manufacturing Investigations at the FleXbatch site in North Carolina. You will manage environmental monitoring investigations, perform root cause analysis, and develop CAPAs to ensure product quality and compliance.

The role requires collaboration across cross-functional teams and effective communication with regulators and management. The position offers exposure to state-of-the-art manufacturing technologies, industry 4.0 capabilities, and a