Jobs · Quality Assurance · North Carolina

Quality Control (QC) Engineer / Analyst

Stark Pharma Solutions Inc · Concord, NC · 2 mo ago
On-siteQuality AssuranceContract

About the role

We are seeking a Quality Control (QC) professional to support laboratory testing and quality assurance activities within a GMP-regulated pharmaceutical manufacturing environment. This role will focus on analytical testing, documentation, and compliance, ensuring products meet quality and regulatory standards.

Responsibilities

  • Perform analytical testing on raw materials, in-process samples, and finished products
  • Document and review test results in compliance with GMP and regulatory requirements
  • Support method validation, verification, and transfer activities
  • Investigate out-of-specification (OOS) and out-of-trend (OOT) results
  • Maintain laboratory equipment and ensure proper calibration and qualification
  • Collaborate with Quality Assurance, Manufacturing, and Validation teams
  • Ensure compliance with FDA, GMP, and company quality standards
  • Support audit readiness and regulatory inspections

Requirements

  • Bachelor's degree in Chemistry, Biology, or related scientific field
  • 6+ years of experience in Quality Control within pharmaceutical or biotech industry
  • Hands-on experience with analytical techniques (e.g., HPLC, GC, UV, etc.)
  • Strong understanding of GMP and regulatory compliance
  • Good documentation and data integrity practices

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