Orca Bio

Supervisor, Quality Control

Sacramento, CA · Full-time

Sponsorship not specified$70k-$110kDetected 137 days ago

GMPFDA RegulatoryLeadershipCommunicationMentoring

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.
We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products.

Lead routine quality control testing on raw materials, process intermediates, and final cell therapy products.
Perform tests, ensure compliance, maintain the lab, prepare reagents, aliquot samples, assist with assay transfer/validation, train staff, and manage supplies.
Manage and support a team of QC analysts, overseeing scheduling, training, and performance evaluations.
Identify opportunities to improve lab operations, workflow efficiency, and compliance practices, and actively participate in revising and developing SOPs and policies.
Collaborate with cross-functional teams to ensure that external requests and activities align with site priorities.
Perform other duties as requested by supervisor/manager to support QualityStay current with industry regulations, standards, and best practices related to quality control.
Team Leadership and Oversight: Manage and support a team of QC analysts, overseeing scheduling, training, and performance evaluations. Provide technical guidance and mentorship to ensure high-quality, compliant practices.
Documentation and Reporting: Review and approve analytical data, protocols, and reports for accuracy and compliance. Maintain metrics for lab performance, deviations, investigations, and audit trail reviews.

Minimum of 5 years of experience in a GMP-regulated QC laboratory, with at least 2 years in a supervisory or lead role.
Strong knowledge of cGMP, FDA, and ICH guidelines.
Proven experience conducting audit trail reviews and leading laboratory investigations.
Most roles 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.
Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.

Bachelor's degree in Chemistry, Biology, or a related scientific discipline (Master's degree 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.