Orca Bio

Specialist, Quality Assurance (Contract Role)

Sacramento, CA · Contract

Sponsorship not specifiedDetected 14 days ago

ComplianceGMPFDA RegulatoryResearchLeadership

About the role

More than one million people in the United States today are fighting blood cancer.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.

Oversee the management of quality systems including deviations, change controls, CAPAs, and document control.
Maintain and improve CAPA processes to ensure effective resolution of quality issues.
Collaborate with manufacturing and quality control teams to ensure all products meet regulatory and quality standards before release.
Monitor and document any quality issues related to batch production and implement corrective measures as necessary.
Document Management:
Maintain the document management system to ensure all quality-related documents are accurate, current, and compliant with regulatory standards.
Training and Support:
Track completion of quality records and maintain metrics.
Perform other duties as requested by supervisor/manager to support Quality
Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products.

Additionally, this role involves making timely batch disposition decisions to ensure quality standards are met before product release, supporting the rapid processing times required by our product.
Must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed.
Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
Must be comfortable regularly participating in video-based meetings.
May be required to work scheduled overtime, weekends, or holidays based on business needs.
Experienced Required
Bachelor's degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.) with 3+ years of experience in quality control testing, analytical development, or GMP
OR a Master's degree in relevant scientific disciplines with 1+ years of experience

Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferred

The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law.

We are driven by a passion for science and compassion for patients.
We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity.
Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn't been paved.
We embrace an entrepreneurial spirit and take calculated risks to achieve our mission.
We aren't afraid to ask "why not" and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We're proud to be 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.
Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening.
Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only.
We do not accept unsolicited resumes, and we rarely outsource recruitment.

This listing is sourced directly from Orca Bio's careers page and normalized into a canonical job model.