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Quality Assurance Specialist
1 month ago
At Orca Bio, we are driven by a passion for science and compassion for patients. We are seeking a highly motivated and detail-oriented Quality Assurance Technician to join our team.
Responsibilities- Review and verify production records, equipment logbooks, and quality control documentation to ensure compliance with cGMP regulations.
- Partner with manufacturing and technical resources to troubleshoot and address equipment issues promptly to minimize downtime.
- Conduct routine walk-throughs of manufacturing and warehouse areas to confirm operations and ensure compliance with cGMP regulations.
- Provide coaching and training to personnel on quality assurance procedures and protocols.
- Perform a variety of tests and inspections to support quality assurance activities.
- Escalate significant issues to organizational leaders as required.
- Collaborate with cross-functional teams to address environmental monitoring-related issues and implement corrective actions.
- 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, and contribute to process improvements.
- Resolve issues as needed with management approval.
- 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.
- No experience is required, but experience in microbiology, environmental monitoring, aseptic technique, or GMP within a cell therapy or biopharmaceutical manufacturing environment is a plus.
Orca Bio offers a competitive salary range of $21-$29 an hour, as well as shift differential pay. Additionally, you will be eligible to receive pre-IPO equity, medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free daily lunches and snacks at our on-site locations.
We are an equal opportunity employer and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients, and their healthcare providers.
