QC Analyst

Job Description

QC Analyst:
On behalf of our Biopharmaceutical client, Procom is searching for a QC Analyst for a 12-month role. This position is an onsite position at our client’s Chapel Hill, North Carolina office.

QC Analyst - Job Description:
The QC Analyst will play a critical role in ensuring the quality and safety of biopharmaceutical products through rigorous testing and analysis. This position involves executing sterility and bioburden testing, supporting the development of analytical procedures, and conducting release and stability testing for patient products.

QC Analyst - Responsibilities:
• Execute Sterility Testing using the BacT Alert Sterility System
• Conduct Bioburden testing using the BacT Alert System
• Develop and execute analytical validations for sterility and bioburden
• Assist in the development of analytical procedures
• Perform Flow Cytometry, PCR, and Endotoxin testing
• Report results using GDP and maintain records in the batch record
• Execute testing on stability programs and document findings
• Train and mentor new employees on QC processes and analytical methods
• Review and execute analytical validations to meet FDA requirements
• Manage Quality Control requirements for new product onboarding
• Investigate existing technology for new product feasibility
• Author, review, and revise forms, job aids, policies, and SOPs
• Participate in 5 hours of continuing education annually in cellular therapy or quality topics

QC Analyst - Mandatory Skills:
• Experience with BacT Alert Sterility and Bioburden Systems
• Familiarity with Flow Cytometry, PCR, and Endotoxin testing
• Strong understanding of GDP and batch record maintenance
• Ability to train and mentor staff
• Experience in analytical validation and statistical analysis
• Excellent problem-solving and communication skills
• Ability to work collaboratively in a team environment

QC Analyst – Nice-to-Have Skills:
• Experience in cellular therapy or related field
• Knowledge of FDA regulatory requirements
• Ability to develop and execute SOPs
• Experience in method development and validation
• Continuing education in quality topics

QC Analyst – Assignment Length:
This is a temporary position with a duration from July 13, 2026, to July 16, 2027.

QC Analyst - Start Date:
ASAP

QC Analyst - Assignment Location:
Chapel Hill, North Carolina, onsite position.