Specialist, Production Project Support

Orcabiosystems
Sacramento, US
On-site

Who this role is best for

Geared toward mid-level professionals comfortable with cross-functional collaboration in a regulated manufacturing environment.

Best fit for

  • Candidates with experience in regulated manufacturing environments will align well.
    — “within a regulated manufacturing environment
  • Individuals skilled in business process improvements and documentation.
    — “business process improvements, change controls, CAPA initiatives
  • Professionals who thrive in cross-functional team settings.
    — “works cross-functionally with production, quality assurance, engineering

Things to consider

  • Role requires adherence to strict compliance standards.
    — “timely and compliant execution of changes

How to stand out

  • Demonstrate expertise in CAPA initiatives and process improvements.
    — “change controls, CAPA initiatives
  • Showcase experience with SOP development in regulated environments.
    — “development and maintenance of Standard Operating Procedures
Pace · SteadyCollaboration · HighAutonomy · MediumDecision Impact · TeamLevel · Junior

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

What success looks like

  • Successfully implemented process improvements
  • Ensured compliance with regulatory standards
  • Developed and maintained SOPs
Typical background
Experience in manufacturing operationsQuality assurance background

Skills & requirements

Required

Project ManagementChange ManagementQuality AssuranceSOP DevelopmentRegulatory Compliance

Preferred

Manufacturing Process ImprovementContinuous Improvement Methodologies

Stack & domain

Cell TherapyManufacturingQuality AssuranceTeamworkProblem-solvingBiotechnologyHealthcare

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 Specialist, Production Project Support supports the execution and documentation of business process improvements, change controls, CAPA initiatives, and the development and maintenance of Standard Operating Procedures (SOPs). This role works cross-functionally with production, quality assurance, engineering, and continuous improvement teams to ensure timely and compliant execution of changes and improvement projects within a regulated manufacturing environment

Source: Orcabiosystems careers (Lever)

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