Summary:
An industry leader in the biopharmaceutical industry is seeking a highly motivated professional to join as a Quality Assurance Specialist in Global QC Team in Santa Monica, CA. You will be tasked with ensuring the quality and timeliness of product to be delivered. You will be working with the Quality team in supporting efforts in a new and exciting area of cancer immunotherapy. This role is a 6 month contract with possible extensions.
Job Duties:
- Disposition raw materials for the company's manufacturing network.
- Review documentation and ensure resolution of issues related to material.
- Ensure all Deviations and CAPAs related to material are initiated, investigated, and resolved.
- Ensure effective root cause analysis and implement corrective/preventative action.
- Oversee material qualification process and specification lifecycle process.
- Support internal and external audits and inspections.
- Support with tracking and communication of quality metrics to management.
Requirements:
- 5+ years of experience with a Bachelor's degree in biological sciences; or
- 3+ years of experience with a Master's degree in biological sciences; or
- 1+ years of experience with a PhD degree in biological sciences.
- Practical knowledge of cGMP regulations, quality systems, and regulatory requirements.
- Practical knowledge of deviations, CAPAs, CC, auditing practices, and disposition.
- Preferred: ASQ, Green Belt certifications.
Competitive wage, full benefits, and excellent chance to work with a prestigious company in biopharma.
