Senior Quality Assurance Specialist
4 days ago
**Job Title:** Senior Quality Assurance Specialist
Estimated Salary:$110,000 - $130,000 per year
About Direct Biologics
Direct Biologics is a leading biotechnology company specializing in advanced regenerative medicine therapies. Our mission is to develop innovative products that improve human health and quality of life.
About the Role
We are seeking an experienced Senior Quality Assurance Specialist to join our team. As a key member of our quality control department, you will play a crucial role in ensuring the safety, efficacy, and quality of our late-stage product.
Main Responsibilities
- Conduct comprehensive analysis of our product using state-of-the-art laboratory techniques and complex equipment.
- Collaborate closely with cross-functional teams including Research and Development, Process Development, Manufacturing, Quality Assurance, and Regulatory Affairs.
- Ensure compliance with all applicable regulatory guidelines and standards, including FDA requirements.
- Lead cGMP method transfer activities from Development to Quality Control.
- 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.
Requirements
- Strong knowledge of analytical techniques such as plate-based ELISA, immunostaining assays, quantitative PCR, and RNA and protein isolation and quantification methods.
- Strong technical understanding and working knowledge of contemporary molecular biology, cell biology, microbiology, and/or biochemistry.
- Highly experienced with current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
- Excellent attention to detail and analytical skills, with the ability to interpret and present data effectively.
- Advanced data management encompassing various statistical analyses such as means, standard deviations, coefficients of variation (% standard deviation), and control charting.
Qualifications
- BA/BS or MS in Biotechnology, biomedical engineering, cell and molecular biology, biochemistry, or other similar biology-related majors.
- Minimum of 5-7 years of experience in a Quality Control role within the pharmaceutical or biotechnology industry performing GMP analytical product testing and/or analytical development.
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