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Quality Control Senior Associate

The Steely Group

Raleigh, NC

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JOB DETAILS
SKILLS
Analytical Chemistry, Biological Assay, Code of Federal Regulations, Continuous Improvement, Cross-Functional, Documentation, Establish Priorities, GMP (Good Manufacturing Practices), Laboratory Information Management System (LIMS), Laboratory Management, Leadership, Manufacturing, Microbiology, Operational Support, Problem Solving Skills, Production Schedule, Quality Control, Risk, Secondary School, Time Management
LOCATION
Raleigh, NC
POSTED
30+ days ago
Responsibilities:
  • Execute QC second shift activities, working with the day and night shift team leads, including sample receipt, prioritization, and accurate entry into LIMS.
  • Serve as a point of contact for Manufacturing during night shift operations, supporting production schedules, issue resolution, and risk escalation.
  • Independently 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.
  • Experience working in a GMP-regulated Quality Control laboratory with demonstrated ability to work independently.
Basic Qualifications    
  • High school/GED + 2 years work experience OR? Associates and 6 months work experience OR? Bachelors

About the Company

T

The Steely Group

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