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Amgen

Makes biotech medicines for serious illnesses

Senior Associate Manufacturing - Manufacturing Investigations

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeHolly Springs, NC, USAIn-person

About the Job

Requirements

  • High school diploma or GED and 4 years of manufacturing and/or other regulated-environment experience, or an associate’s degree and 2 years of such experience, or a bachelor’s degree and 6 months of such experience, or a master’s degree.
  • Preferred: 3 or more years of related work experience in manufacturing, microbiology, process development, or quality assurance in the biotechnology 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 such as 5 Whys and fishbone analysis, critical thinking, project management, and quality systems.
  • A degree in science or engineering is preferred; microbiology or a similar field is a plus.
  • Experience leading investigations is preferred.
  • Experience using Veeva QMS for deviation investigations and corrective and preventive actions is preferred.
  • Demonstrated project management ability is preferred.
  • Ability to work in a team matrix environment and build relationships with partners is preferred.

Responsibilities

  • Manage simple deviation and environmental monitoring investigations, specifically in controlled environmental monitoring, leading root cause analysis, developing corrective and preventive actions, and documenting findings compliantly.
  • Apply basic 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.
  • Communicate investigation progress to impacted areas and leadership.
  • Coordinate and lead cross-functional teams through investigations and complete milestones on schedule.
  • Present investigation findings and technical information to diverse audiences, communicating moderately complex issues clearly and concisely.
  • Navigate ambiguity and apply a structured problem-solving approach and inductive and deductive reasoning to investigations.
  • Prepare clear and concise technical documentation.
  • Use Operational Learning Team strategies to promote open collaboration with staff and maximize investigation findings.
  • Develop tracking tools to ensure on-time closure and proactive review of deviation investigations.

Desired Qualifications

  • Preferred: Basic understanding of drug substance manufacturing, environmental monitoring programs, and contamination control principles.
  • Preferred: Experience with compliance, problem-solving, simple and complex root cause analysis tools such as 5 Whys and fishbone analysis, critical thinking, project management, and quality systems.
  • Preferred: A degree in science or engineering; microbiology or a similar field is a plus.
  • Preferred: Experience leading investigations.
  • Preferred: Experience using Veeva QMS for deviation investigations and corrective and preventive actions.
  • Preferred: Demonstrated project management ability.
  • Preferred: Excellent written and verbal communication skills.
  • Preferred: Ability to work in a team matrix environment and build relationships with partners.
  • Preferred: Strong interpersonal skills.

About the Company

Amgen

Makes biotech medicines for serious illnesses

Amgen develops and makes biologic medicines, which are drugs built from proteins and antibodies grown in living cells, for serious conditions such as heart disease, cancer, and bone loss. Its anemia drug Epogen, approved in 1989, became one of the biotechnology industry's first blockbuster medicines. Amgen grows these drugs in large tanks called bioreactors, and its products include the cholesterol drug Repatha, the bone-building drug Evenity, and the severe asthma drug Tezspire. It earns money by selling these medicines, mostly through large drug wholesalers that supply hospitals and pharmacies. Amgen was founded in 1980 and is based in Thousand Oaks, California.

Company size
10,001+
Company stage
IPO
Headquarters
Thousand Oaks, CA
Founded
1980

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