Amgen-posted 6 months ago
$81,082 - $98,151/Yr
Full-time • Entry Level
Holly Springs, NC
Chemical Manufacturing

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

  • Support the site QC systems team.
  • Own and author change controls and investigation records to support initial lab equipment installation, qualification, and validation.
  • Implement computerized systems and establish the QC GMP processes.
  • Transition to routine record ownership.
  • Work collaboratively with Quality and Quality Assurance teams to author and own change records and deviations.
  • Lead investigation teams and help to collect and report metrics for the systems team.
  • Assist with review of validation documents to support equipment and computerized system onboarding.
  • Author, revise and review documents and reports including SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, technical reports.
  • Support the startup of a GMP QC laboratory.
  • Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
  • Support routine activities over the weekends and public holidays as required.
  • High School/GED + 4 years of Quality work experience OR Associate's + 2 years of Quality work experience OR Bachelor's + 6 months of Quality work experience OR Master's.
  • Degree in a related scientific field such as Chemistry, Microbiology, Molecular Biology, Physics or Engineering.
  • 3-5 years of relevant laboratory experience in the GMP commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred.
  • Solid understanding of aseptic technique.
  • Proficient in the use of Veeva and Trackwise systems.
  • Experience in a lead role, providing guidance to team members.
  • Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery.
  • Strong written and verbal communication skills including technical writing and presentation.
  • Familiar with authoring or owning change control records.
  • Experience with equipment and method validation, verification, and transfer including the change control process.
  • Interact effectively with variety of communication and working styles and ability to work well in teams.
  • Competitive and comprehensive Total Rewards Plans aligned with local industry standards.
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