Technician, Quality Assurance - Day Shift
About The Position
The Technician, Quality Assurance plays a critical role in supporting the production of Orca Bio’s life-saving cell therapy products by ensuring adherence to strict quality standards, cGMP compliance, and real-time production support. Reporting into the Quality Assurance leadership team, this position provides on-the-floor QA oversight, conducts real-time record and documentation review, and partners with manufacturing and technical teams to identify and resolve issues. The role collaborates closely with Manufacturing, Quality Control (QC), and other Quality functions to maintain seamless operations in a highly regulated environment.
Requirements
- Ability to wear cleanroom gowning and adhere to cleanroom entry and gowning requirements
- Demonstrated ability to identify and support resolution of technical issues
- Familiarity with cGMP regulations and documentation practices
- Proven experience collaborating in cross-functional or project teams
- Strong attention to detail and ability to follow QA processes and escalation pathways
Nice To Haves
- Coursework or experience in a scientific discipline (e.g., biology, microbiology, environmental science), including A.S. or B.S. degree
- Prior experience in a regulated environment (e.g., GMP, biopharma, or cell therapy manufacturing)
- Understanding of aseptic technique, environmental monitoring, and microbiology principles
- Strong organizational, communication, and problem-solving skills
- Ability to adapt quickly in a dynamic, fast-paced environment and manage shifting priorities
- Experience contributing to investigations, CAPAs, or other QA system elements
Responsibilities
- Perform real-time review of production records, equipment logbooks, and QC documentation to ensure compliance with good documentation practices and cGMP requirements
- Partner with manufacturing and technical staff to review records and ensure product quality rationale supports batch disposition decisions
- Support real-time troubleshooting of equipment or production issues to minimize downtime and ensure uninterrupted manufacturing
- Conduct routine walkthroughs of classified areas (manufacturing and warehouse) to verify compliance with cGMP standards
- Escalate significant issues to QA and operational leadership as appropriate
- Provide coaching, training, and guidance to internal teams regarding compliance, documentation, and best practices
- Collaborate cross-functionally to address deviations and implement corrective and preventive actions (CAPA)
- Support broader QA functions as needed, including document control and deviation management
- Participate in continuous improvement efforts to enhance quality systems, efficiency, and compliance
Benefits
- pre-IPO equity
- annual bonus
- competitive medical, dental, and vision benefits
- PTO
- 401(k) plan
- life and accidental death and disability coverage
- parental leave benefits
- subsidized daily lunches and snacks
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
