An exciting and euthanistic Biotechnology company, located in Santa Monica, CA is hiring for a Quality Assurance Specialist I to join them on their team to ensure compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines. This is an onsite 6 month contract with the chance to expand looking to start around JAN 2023.
Additional responsibility that the candidate may inquire perform activities to ensure compliance with applicable quality objectives and regulatory requirements including:
- Review batch-related documentation and ensure resolution of issues to release product.
- Oversee material qualification process, approve material qualification protocols, reports.
- Manage Change Control system and ensure proper maintenance and approval of cGMP documents.
- Manage the Deviation and CAPA system and ensure timely closure and effectiveness of investigations and corrective
- Provide QA guidance to material development projects and technical transfer activities.
- Provide data for Quality related metrics
- Degree in the biological sciences or related field
- Direct management/leadership experience in a pharmaceutical or biologics operation.
- Experience in identifying, writing, evaluating and closing CAPAs.
- Experience with conducting and managing internal and external audits.
- Strong knowledge of change control practices/strategies.
Please apply with your most up to date resume to be considered.