Quality Control (QC) Engineer / Analyst

Stark Pharma; Concord (NC); On-site; USD 60,000 - 80,000; Full time

Job summary

Stark Pharma in Concord, NC is looking for a Quality Control (QC) Engineer / Analyst to support laboratory testing in a GMP-regulated environment. The role requires 2-6+ years of QC experience, strong analytical skills, and a Bachelor's degree in a relevant scientific field. Responsibilities include performing analytical tests, documenting results, supporting method validation, and ensuring compliance with regulatory standards. This is a long-term contract position focused on maintaining high-quality standards.

Qualifications

• 2-6+ years of experience in Quality Control within the pharmaceutical or biotech industry.
• Hands-on experience with analytical techniques (e.g., HPLC, GC, UV).
• Strong understanding of GMP and regulatory compliance.

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.

Skills

Analytical techniques (HPLC, GC, UV)

GMP compliance

Documentation practices

Data analysis

Education

Bachelor's degree in Chemistry, Biology, or related field

Job description

Job Title: Quality Control (QC) Engineer / Analyst

Location: Concord, NC (Onsite)

Duration: Long Term Contract

Job Summary

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. The ideal candidate will have hands‑on experience in QC testing, data analysis, and GMP documentation within pharma or biotech settings.

Key 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.

Required Qualifications

• Bachelor's degree in Chemistry, Biology, or related scientific field.
• 2-6+ 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.