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Associate Quality Control - Night Shift

The Steely Group

Holly Springs, NC

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JOB DETAILS
SKILLS
Analytical Chemistry, Asepsis, Biological Assay, Code of Federal Regulations, Continuous Improvement, Cross-Functional, Documentation, Establish Priorities, GMP (Good Manufacturing Practices), Laboratory Information Management System (LIMS), Leadership, Microbiology, Quality Control, Secondary School, Time Management
LOCATION
Holly Springs, NC
POSTED
30+ days ago
Responsibilities:
  • Execute QC activities, working with the day and night shift managers, including sample receipt, prioritization, and accurate entry into LIMS.
  • Perform routine and complex analytical testing in chemistry, bioassay, and/or microbiology, including STAT testing as required.
  • Ensure accurate, compliant documentation in accordance with GDP, GMP, and 21 CFR Part 11 requirements.
  • Support laboratory investigations related to deviations or OOS results and communicate shift-level risks to QC leadership.
  • Utilize electronic systems including LIMS, Biovia (LES, ELN, CIMS/CISPro), and Veeva Vault (QualityDocs, QMS).
  • Collaborate cross-functionally to meet testing timelines and contribute to continuous improvement initiatives.
Basic Qualifications    
  • High school/GED + 2 years work experience or Associates degree and 6 months work experience or Bachelors degree
Preferred Qualifications:
  •  Bachelor’s degree in a scientific discipline or equivalent experience, entry level will be considered.
  • Experience working in a GMP-regulated environment and ability to work independently.
  • Laboratory or aseptic knowledge

About the Company

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The Steely Group