Quality Assurance Associate
Discovery Life Sciences
Summary
Discovery Life Sciences is a global market leader in biospecimen procurement, analysis, distribution, and scientific services for the pharmaceutical, biotechnology, and diagnostics industries. Founded in 2018 and headquartered in Huntsville, Alabama, the company operates as the 'Biospecimen and Biomarker Specialists,' combining the world's largest commercial biospecimen inventory and procurement network with globally recognized multi-omic analytical service laboratories. With over 10 million biospecimens in its biobank and hundreds of global clinical sites, Discovery provides highly characterized human cellular starting materials and expert services to accelerate precision medicine programs for cancer, infectious diseases, and other complex conditions. The company's integrated platform includes genomics, proteomics, molecular pathology, cell biology, and clinical flow cytometry services, supporting over 1,000 clinical trial programs. Discovery serves leading biopharmaceutical companies, diagnostic developers, and academic institutions, enabling them to advance cell and gene therapy research, development, and manufacturing programs with a single-vendor approach that eliminates inefficient transfers between different providers.
Job description
A Day in the Life of a Quality Assurance Associate
- Review batch records, manufacturing documentation, and supporting quality records to ensure GMP compliance and readiness for product release.
- Partner with Manufacturing and Operations teams to resolve documentation discrepancies, clarify deviations, and ensure all records are completed accurately and in a timely manner.
- Issue, control, and maintain GMP documentation within the Quality Management System, ensuring adherence to Good Documentation Practices (GDP).
- Support product release activities by coordinating required testing, reviewing analytical results, and verifying that all release criteria have been met.
Key Responsibilities
- Perform issuance, review, approval, and control of GMP-quality documentation, batch records, and associated records.
- Conduct thorough document reviews to ensure compliance with GMP, GDP, internal procedures, and regulatory requirements.
- Support product release and disposition activities through review of manufacturing, testing, and quality documentation.
- Collaborate with Manufacturing, Operations, Collection Centers, and external partners to resolve documentation issues and quality concerns.
- Support the maintenance and continuous improvement of the Quality Management System (QMS) in alignment with applicable regulatory standards.
- Assist with environmental monitoring, sample retention, document control, and other quality assurance programs as assigned.
- Support quality training initiatives and educate employees on quality expectations, regulatory requirements, and best practices.
- Identify, escalate, and track quality events, deviations, and compliance risks to ensure timely resolution.
- Serve as an advocate for quality throughout the organization and promote a culture of continuous improvement and compliance.
- Support internal audits, inspections, and quality initiatives as needed.
Requirements
- Bachelor's degree within life sciences or a related scientific discipline preferred
- At least 2 years' experience in Quality Assurance, Quality Systems, or related quality function in a GMP regulated environment
- Experience reviewing and approving GMP-controlled documentation required, including batch records, manufacturing records, or product release documentation
- Working knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
- Strong attention to detail and ability to prioritize multiple tasks
- Excellent computer skills and MS Office proficiency (including MS Word and Outlook)
Benefits
- Competitive Salary
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Coverage
- 401(k) Match
- Paid Vacation
- Paid Time Off
- Paid Parental Leave
- Paid Family Leave
- Professional Development
- Certification Reimbursement
- Tuition Reimbursement
- Team-Building Activities
- Employee Referral Program
- Colleague Recognition Program
Company overview
Discovery Life Sciences is a global market leader in biospecimen procurement, analysis, distribution, and scientific services for the pharmaceutical, biotechnology, and diagnostics industries. Founded in 2018 and headquartered in Huntsville, Alabama, the company operates as the 'Biospecimen and Biomarker Specialists,' combining the world's largest commercial biospecimen inventory and procurement network with globally recognized multi-omic analytical service laboratories. With over 10 million biospecimens in its biobank and hundreds of global clinical sites, Discovery provides highly characterized human cellular starting materials and expert services to accelerate precision medicine programs for cancer, infectious diseases, and other complex conditions. The company's integrated platform includes genomics, proteomics, molecular pathology, cell biology, and clinical flow cytometry services, supporting over 1,000 clinical trial programs. Discovery serves leading biopharmaceutical companies, diagnostic developers, and academic institutions, enabling them to advance cell and gene therapy research, development, and manufacturing programs with a single-vendor approach that eliminates inefficient transfers between different providers.