Sr Associate Mfg I- Investigations

amgen; Holly Springs (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

Amgen’s North Carolina Biologics Facility seeks a Senior Associate Manufacturing I – Investigations to lead deviation investigations and monitor containment of issues impacting product quality. You will interface with GMP manufacturing teams, Process Development, Facilities & Engineering, and Quality to ensure thorough, compliant investigations and CAPAs.

You will communicate findings, present to regulators, and drive improvements in the investigation process while navigating ambiguity with

Qualifications

• Master’s degree in a relevant field.
• Bachelor’s degree plus 6 months of directly related work experience.
• Associate’s degree plus 2 years of directly related work experience.
• High school/GED plus 4 years of directly related work experience.
• 3+ years related work experience in biotech/pharma with increasing responsibility.
• Basic understanding of Drug Substance manufacturing and environmental monitoring.

Responsibilities

• Manage deviation and environmental monitoring investigations with root cause analysis and CAPA documentation.
• Present investigations to regulatory inspectors and internal auditors.
• Lead cross-functional teams through investigations and meet milestones.
• Communicate investigation progress to leadership and impacted areas.
• Develop tracking tools to ensure on-time closure of investigations.
• Apply structured problem-solving approaches and inductive/deductive reasoning in investigations.

Skills

Investigation leadership

Project management

Communication skills

Root cause analysis

Quality systems

Team collaboration

Interpersonal skills

Education

Master’s degree

Bachelor’s degree + 6 months related experience

Associate’s degree + 2 years related experience

High school/GED + 4 years related experience

Tools

Veeva QMS

Job description

Senior Associate Manufacturing I – Investigations

What you will do

Let’s do this. Let’s change the world. In this vital role you will be a key member of the team that investigates major deviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and interface between the GMP manufacturing teams and stakeholder groups including Process Development, Facilities & Engineering, Automation, EHSS, and Quality. This position is responsible for ensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process.

• Manage simple deviation and environmental monitoring investigations, specifically within the Controlled Environmental Monitoring space, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.

• Apply a basic understanding of microbiology principles, environmental monitoring programs, and contamination control strategies to support environmental monitoring investigations.

• Interpret environmental monitoring data, identify trends, and assess potential impacts to product quality, manufacturing operations, and contamination control programs.

• 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 investigations, and complete milestones on‑schedule.

• Present investigation findings and technical information to diverse audiences and communicate moderately complex issues in a clear and concise manner. 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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

Basic Qualifications

• Master’s degree
• Bachelor’s degree & 6 months of directly related work experience
• Associate’s degree & 2 years of directly related work experience
• High school/GED & 4 years of directly related work experience

Preferred Qualifications

• 3+ years related work experience (manufacturing, microbiology, process development, or quality assurance) 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, simple and complex root cause analysis tools (5-whys, fishbone etc.) critical thinking, project management, and quality systems.
• Degree in Science or Engineering (Microbiology or similar a plus)
• Experience leading investigations
• Experience using Veeva QMS for Deviation investigations and CAPAs
• Demonstrated project management ability
• Excellent written and verbal communication skills
• Ability to work in a team matrix environment and build relationships with partners
• Strong interpersonal skills

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan
• Stock‑based long‑term incentives
• Award‑winning time‑off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.