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QC Associate I

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Amgen

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Location:
United States , Holly Springs

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

66222.00 - 82012.00 USD / Year
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Job Description:

Performing testing within the Quality Control Microbiology laboratory. Responsibilities will include sampling and testing to support clean utilities qualification and establishment of the environmental monitoring program to deliver site start up and then transition to testing in support of Amgen North Carolina commercial product release. Scope includes in-process, release, stability and routine monitoring testing.

Job Responsibility:

  • Support document review and authoring, including but not limited to: SOPs, safety assessments, methods, trend reports, microorganism assessments, and technical reports
  • Assist with execution of EMPQ activities to support establishment of environmental monitoring program
  • Perform routine environmental monitoring and utilities sampling
  • Perform routine quality control testing, including Bioburden, Endotoxin, conductivity and TOC
  • Participate in audits, initiatives, and projects that may be interdepartmental or global in scope
  • Participate in deviations, CAPAs, and cross functional investigations
  • Assist with general lab setup and 5S
  • Support routine activities over the weekends and public holidays as required
  • Assist with clean utilities performance qualifications, including water for injection, clean steam, clean compressed air, oxygen, and carbon dioxide distribution systems
  • Perform routine tasks such as cleaning and inventory management

Requirements:

  • High school/GED + 2 years of related GxP laboratory experience
  • Associate’s + 6 months of related GxP laboratory experience
  • Bachelor’s

Nice to have:

  • Experience working in a GMP pharmaceutical production facility with classified areas and applicable gowning requirements
  • Degree in Microbiology, Biology, Biochemistry, or related scientific field
  • Experience with microbiological quality control testing, including but not limited to: Endotoxin, Bioburden, Microbial Identification, TOC, PCR
  • Strong knowledge of aseptic technique
  • Experience with environmental monitoring and clean utilities monitoring
  • Proficient in Good Documentation Practices
  • Strong written and verbal communication skills, including technical writing and technical presentations
  • Able to flexibly work independently with minimal supervision and collaboratively on group tasks
What we offer:
  • 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

Additional Information:

Job Posted:
February 20, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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