Overview
Associate Specialist, Quality Assurance Jobs in Tustin, CA at BioTalent
Title: Associate Specialist, Quality Assurance
Company: BioTalent
Location: Tustin, CA
Associate Specialist, Quality Assurance
Location: Tustin, CA
About the Role
We are partnering with a leading biologics contract development and manufacturing organization (CDMO) dedicated to advancing and manufacturing life-changing biopharmaceutical therapies. They are seeking an Associate Specialist, Quality Assurance to support quality systems, document control, training administration, and GMP compliance activities. This role offers an excellent opportunity to contribute to a highly regulated biopharmaceutical environment while supporting quality initiatives that ensure operational excellence and inspection readiness.
Key Responsibilities
- Administer and maintain electronic document management systems to ensure accurate control of quality documentation.
- Support electronic training systems, including curriculum assignments, training report generation, and curriculum updates.
- Issue, reconcile, and maintain equipment logbooks, laboratory notebooks, SOPs, forms, logs, and other controlled documents.
- Archive and retrieve quality records and documentation in accordance with internal procedures and regulatory requirements.
- Provide formal and informal training to employees on quality systems, GMP requirements, and training processes.
- Assist internal teams and external customers with document requests, revisions, and quality-related support activities.
- Collaborate cross-functionally to ensure timely and effective completion of document reviews and quality processes.
- Participate in departmental and cross-functional process improvement initiatives.
- Enforce Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) across operations.
- Support internal audits, regulatory inspections, and ongoing inspection readiness efforts.
- Perform additional quality assurance responsibilities as assigned by management.
Qualifications & Requirements
- B.S. degree in Biological Sciences, Biotechnology, Biochemistry, Molecular Biology, or a related scientific discipline.
- 1+ years of experience in the biopharmaceutical, biotechnology, pharmaceutical, or regulated life sciences industry.
- Knowledge of cGMP regulations and quality systems.
This position is not eligible for visa sponsorship or support such as H1B, TN, E-3, CPT, OPT, STEM OPT, or employment-based permanent residence processes, now or in the future.
