Senior Associate, Manufacturing Investigations (Remote)

BioSpace; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Comprehensive benefits package

Discretionary annual bonus program

Stock-based long-term incentives

Flexible work models including remote,

Job summary

Amgen, in North Carolina, seeks a Senior Associate Manufacturing Investigations to join the team responsible for investigating major deviations at the Biologics Drug Substance Manufacturing plant. You will interface with GMP manufacturing teams and stakeholders, drive investigation quality, and lead cross-functional teams to closure.

The role emphasizes rigorous technical writing, regulatory communication, and structured problem solving, with a focus on environmental monitoring and contamination

Qualifications

• High School Diploma/GED plus 4 years in manufacturing or regulated environment.
• Associate's Degree plus 2 years manufacturing or regulated environment experience.
• Bachelor's Degree plus 6 months manufacturing or regulated environment experience.
• Master's Degree.
• 3+ years related work experience in biotech or pharmaceutical industry with progressively increasing responsibility.
• Basic understanding of Drug Substance manufacturing, environmental monitoring programs, and contamination control principles.
• Experience with compliance, problem-solving, and root cause analysis tools (5-why, fishbone, etc.).
• Demonstrated project management ability and strong communication skills.

Responsibilities

• Manages simple deviation and environmental monitoring investigations within the Controlled Environmental Monitoring space, leading root cause analysis and CAPA development.
• Apply microbiology principles to support environmental monitoring investigations.
• Interpret environmental monitoring data, identify trends and assess potential impact on product quality and operations.
• Present investigations to regulatory inspectors, internal auditors, and management.
• Communicate investigation progress to impacted areas and leadership.
• Coordinate and lead cross-functional teams through investigations and milestones on schedule.
• Present findings clearly to diverse audiences and maintain strong cross-functional relationships.

Skills

GMP manufacturing

Environmental monitoring

Root cause analysis

Cross-functional teamwork

Regulatory communication

Problem solving

Education

High School Diploma/GED

Associate Degree

Bachelor's Degree

Master's Degree

Job description

Amgen, in North Carolina, seeks a Senior Associate Manufacturing Investigations to join the team responsible for investigating major deviations at the Biologics Drug Substance Manufacturing plant. You will interface with GMP manufacturing teams and stakeholders, drive investigation quality, and lead cross-functional teams to closure.

The role emphasizes rigorous technical writing, regulatory communication, and structured problem solving, with a focus on environmental monitoring and contamination