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