Supervisor, Quality Control

Orcabiosystems
Sacramento, US
On-site

Who this role is best for

Best suited to mid-level professionals with experience in regulatory compliance and laboratory operations working in biotechnology.

Best fit for

  • Candidates with regulatory compliance expertise in laboratory settings
    — “ensuring compliance with regulatory standards, internal procedures
  • Individuals experienced in leading investigations of lab anomalies
    — “leading investigations of out-of-specification (OOS) results
  • Professionals comfortable with rotating 12-hour shift schedules
    — “Day Shift: • 6:00am to 6:30pm or

Things to consider

  • Requires working long 12-hour shifts including nights
    — “Night Shift: • 6:00pm to 6:30am
  • Must be available for every other Wednesday shifts
    — “Sunday, Monday, Tuesday + every other Wednesday

How to stand out

  • Highlight specific instances where you improved lab inspection readiness
    — “ensuring the lab remains in a consistent state of inspection readiness
  • Detail your process for maintaining data integrity in audits
    — “maintaining data integrity through audit trail reviews
  • Showcase experience with high-precision cell therapy environments
    — “consistent and reliable delivery of our high-precision cell therapy products
Pace · SteadyCollaboration · HighAutonomy · MediumDecision Impact · TeamLevel · Mid

Derived from job-description analysis by Serendipath's career intelligence engine.

What success looks like

  • Maintaining compliance
  • Leading investigations
Typical background
Quality control experienceLaboratory management

Skills & requirements

Required

Quality ControlRegulatory ComplianceData IntegrityLaboratory Management

Preferred

Manufacturing ExperienceBiotechnology

About the role

Original posting from Orcabiosystems via Lever

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.

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. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.

The Supervisor, Quality Control (QC) is responsible for overseeing daily operations within the QC laboratory to ensure compliance with regulatory standards, internal procedures, and quality expectations. This position plays a critical role in maintaining data integrity through audit trail reviews, leading investigations of out-of-specification (OOS) results and deviations, and ensuring the lab remains in a consistent state of inspection readiness.

We are multiple positions across the following schedules:

Day Shift:

  • 6:00am to 6:30pm or
  • 6:30am to 7:00pm

Night Shift:

  • 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

Source: Orcabiosystems careers (Lever)

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