QC Analyst

We are seeking a Quality Control (QC) Analyst to join our innovative research team in Chapel Hill, NC. This is an exciting opportunity to contribute to cutting-edge health sciences research while supporting the development and release of life-changing cellular therapy products. You'll collaborate with a multidisciplinary team dedicated to advancing basic, translational, mechanistic, and population-based research in a GMP-regulated environment.

The ideal candidate will have a strong background in analytical testing, quality control, and laboratory operations, along with a passion for scientific excellence and continuous improvement.

Chapel Hill, NC

Pay: $33.65–$36.06/hour

1 year contract with possibility of conversion or extension

Desired Qualifications

• Bachelor's degree in Biology, Microbiology, Biochemistry, Biotechnology, Chemistry, or another related life science field OR
• 3+ years of relevant Quality Control, Analytical Development, GMP, or pharmaceutical/biotechnology laboratory experience
• Experience working in a regulated GMP environment is highly preferred.
• Strong analytical, documentation, and problem-solving skills.

Key Responsibilities

Sterility & Bioburden Testing

• Perform sterility testing using the BacT/ALERT Sterility System.
• Conduct bioburden testing utilizing the BacT/ALERT System.
• Develop, validate, and optimize sterility and bioburden analytical methods.
• Assist with the development and implementation of analytical procedures supporting microbiological testing.

Release & Stability Testing

• Perform release and stability testing for manufactured patient products.
• Utilize analytical techniques including Flow Cytometry, PCR, and Endotoxin testing.
• Document test results accurately using Good Documentation Practices (GDP) and maintain complete batch records.
• Support stability programs by executing testing, documenting findings, and reporting results.
• Train and mentor laboratory personnel on QC testing procedures and analytical methodologies.

Analytical Development

• Execute analytical method validations and revalidations to ensure compliance with current FDA and regulatory requirements.
• Review existing validation protocols for continued suitability.
• Analyze laboratory data, perform statistical evaluations, and support interpretation of results.
• Assist with analytical data review and continuous process improvements.

New Product & Method Implementation

• Support onboarding of new products by coordinating all Quality Control activities.
• Collaborate with Manufacturing and cross-functional teams on method development, validation, SOP creation, and material acquisition.
• Evaluate new technologies and testing methodologies to support future product development.
• Expand site knowledge of analytical testing methods and best practices.

Documentation & Compliance

• Author, review, and revise Standard Operating Procedures (SOPs), forms, policies, and job aids.
• Ensure compliance with GMP, FDA, and internal quality standards.
• Participate in a minimum of five hours of continuing education annually in cellular therapy, quality systems, or related scientific topics.
• Perform additional responsibilities as assigned to support departmental and organizational goals.
• **This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you**

INDBH