Quality Control Analyst - GMP Analytical & Molecular Testing

Direct Biologics is a leading regenerative medicine biotechnology company seeking a Quality Control Analyst who will ensure the safety, identity, purity, potency, and overall quality of drug substance and drug product. The role requires strong technical expertise in molecular and cell-based assays, deep knowledge of GMP documentation standards, and the ability to independently drive investigations and process improvements in a regulated environment.

Requirements

• Perform day-to-day drug substance and drug product testing using a range of analytical techniques
• Ensure compliance with all applicable regulatory guidelines and standards, including FDA requirements
• Conduct product characterization studies to assess the identity, purity, and potency of samples
• Perform stability testing to evaluate the shelf-life and storage conditions of products
• Prepare, analyze, review, troubleshoot, and evaluate a wide array of GMP analytical assays
• Compile QC data, perform data trending, and control chart monitoring
• Author SOPs and Test Records and Training Plans with a Quality-by-Design (QbD) mindset

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Company 401k match up to 4%
• Paid Time Off (Vacation & Sick)
• Holidays
• Stock Option