Direct Biologics
Quality Control Analyst - GMP Analytical & Molecular Testing
Poway, California, United States
Sponsorship not specified$75k-$95kDetected 145 days ago
Process ImprovementGMPFDA RegulatoryPCRqPCRMolecular BiologyProtein AnalysisTime Management
About the role
- Our team is committed to advancing high-quality, compliant, and clinically meaningful products that improve patient outcomes.
- This individual will play a critical role in ensuring the safety, identity, purity, potency, and overall quality of our drug substance and drug product.
- The Quality Control Analyst is responsible for executing GMP analytical testing for release and stability, supporting product characterization, and maintaining rigorous compliance with FDA and cGMP standards.
Responsibilities
- Perform day-to-day drug substance and drug product testing using a range of analytical techniques, such as plate-based ELISA, immunostaining assays, quantitative PCR, and methods for RNA and protein isolation and quantification.
- Lead cGMP method transfer activities from Development to Quality Control while providing regular progress updates to drive timelines.
- 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 under established protocols and procedures following the change control process to implement process improvement and process change.
- Compile QC data, perform data trending, and control chart monitoring.
- Document and analyze test results, generating reports that provide clear and concise findings.
- Serve as SME (Subject Matter Expert) for QC testing and collaborate for transfer and release activities.
- Author SOPs and Test Records and Training Plans with a Quality-by-Design (QbD) mindset.
- Partner with Process and Analytical Development and other departments in the design, testing, evaluation, and improvement of processes and controls.
- Support Process and Analytical Development with additional studies.
Requirements
- Minimum of 3-7 years of experience in a Quality Control role within the pharmaceutical or biotechnology industry performing GMP analytical product testing and/or analytical development.
Nice to have
- Familiarity with statistical software preferred.
Compensation
- $75,000 - $95,000 annually Health Care Plan (Medical, Dental & Vision) Company 401k match up to 4% Paid Time Off (Vacation & Sick) Holidays Stock Option
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This listing is sourced directly from Direct Biologics's careers page and normalized into a canonical job model.