QC Analyst

QC Analyst

Quality Control

Chapel Hill, North Carolina, US

• Added - 26/06/2026

Pay Rate Low: 33.65 | Pay Rate High: 36.06

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#LI-KR1

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.