Quality Assurance Specialist
4 weeks ago
Orca Bio is seeking a Quality Assurance Technician to support our commercial manufacturing facility in Sacramento, CA. This role will play a critical part in ensuring the quality of our cell therapies and supporting the development of next-generation treatments.
Key Responsibilities- Review and verify production records, equipment logbooks, and QC documentation to ensure compliance with cGMP regulations.
- Partner with manufacturing and technical resources to troubleshoot equipment issues and minimize downtime.
- Walk-through manufacturing and warehouse areas to confirm operations and ensure cGMP compliance.
- Provide coaching and training to personnel on quality assurance procedures and protocols.
- Perform a variety of tests and activities to support quality assurance efforts.
- Ability to wear cleanroom gowning and meet the requirements of controlled, classified spaces.
- Perform shift work to support 24-hour manufacturing operations.
- Identify and support resolution of technical problems.
- Actively participate in group and project teamwork; project and process improvements.
- Adhere to cGMP policies and procedures, including documentation activities.
- Classes in a relevant scientific discipline (biology, microbiology, environmental science, etc.).
- Excellent organizational, communication, and problem-solving skills.
- Detail-oriented with a strong commitment to data integrity and accuracy.
- Ability to work independently and as part of a team in a fast-paced and regulated environment.
- Adaptable and responsive to changing priorities and challenges.
Orca Bio offers a competitive salary range of $21-$29 an hour, shift differential pay, and a comprehensive benefits package, including medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. We also offer free daily lunches and snacks at our on-site locations.
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