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Jobs · Information Technology · California

Associate, Packaging Operations and Cold Chain Handling - Night Shift

Orca Bio · Sacramento, CA · 2 wk ago
On-siteInformation Technology$24–$26/hrFull-time

About the role

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. 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.

Responsibilities

  • Receive and verify incoming apheresis materials according to SOPs and regulatory requirements.
  • 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.
  • Cryopreserve intermediate and final cellular products.
  • Operate and maintain cryogenic storage equipment (e.g., controlled-rate freezers, LN2 tanks).
  • Accurately complete batch records and electronic documentation systems.
  • Cook label, package, and release drug product for shipment.
  • Prepare shipping materials, confirm shipping conditions (e.g., temperature control), and liaise with logistics partners.
  • Ensure real-time data entry into inventory, tracking systems and eBRs.
  • Support deviation investigations, CAPAs, and continuous improvement initiatives as needed.
  • Maintain accurate and complete records in accordance with GMP and GDP standards.

Requirements

  • 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.
  • Strong understanding of cell therapy manufacturing processes.
  • Strong attention to detail, organizational skills and document accuracy.
  • Ability to work with biological materials and cryogenic systems.
  • Knowledge of regulatory compliance (FDA and GxP) a plus.
  • Comfortable working in a clean room and or cold environment (Liquid Nitrogen storage).

Qualifications

  • Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
  • 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.

Skills

  • Strong understanding of cell therapy manufacturing processes.
  • Strong attention to detail, organizational skills and document accuracy.
  • Ability to work with biological materials and cryogenic systems.
  • Knowledge of regulatory compliance (FDA and GxP) a plus.

Benefits

  • Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits.
  • Other perks include subsidized daily lunches and snacks at our on-site locations.

Pay

$65,465 - $71,571 a year

Schedule

Night Shift Hours Worked: 6:00pm to 6:30am or 6:30pm to 7:00am
Work Week Schedule: Sunday, Monday, Tuesday + every other Wednesday or Thursday, Friday, Saturday + every other Wednesday

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