Orca Bio

Associate, Packaging Operations and Cold Chain Handling - Night Shift

Sacramento, CA · Full-time

Sponsorship not specified$65k-$72kDetected 137 days ago

ComplianceSupply ChainLogisticsGMPFDA RegulatoryLeadershipOrganizational SkillsGxP

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 role will operate with a deep understanding of GMP manufacturing, cell therapy processes, and the ability to execute multiple tasks in a fast-paced environment.

Perform visual inspections and documentation checks to ensure proper labeling, temperature, and packaging.
Maintain strict adherence to chain-of-identity and chain-of-custody procedures.
Operate and maintain cryogenic storage equipment (e.g., controlled-rate freezers, LN2 tanks).
Prepare shipping materials, confirm shipping conditions (e.g., temperature control), and liaise with logistics partners.
Perform other duties as assigned
Support deviation investigations, CAPAs, and continuous improvement initiatives as needed.
Maintain accurate and complete records in accordance with GMP and GDP standards.

Strong understanding of cell therapy manufacturing processes
Ability to work with biological materials and cryogenic systems
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.

Bachelor's degree in Life Sciences, Engineering, or related field preferred.
1-3 years of experience in a GMP-regulated biotech or pharmaceutical environment preferred.
Knowledge of regulatory compliance (FDA and GxP) a plus

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.