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QC Specialist Operations

Company: Atara Biotherapeutics, Inc.
Location: Thousand Oaks
Posted on: May 3, 2021

Job Description:

The QC Specialist will play an integral role in developing and maintaining a system to effectively manage laboratory equipment for Quality Control (QC) at Atara.  This system will cover the equipment throughout its lifecycle from installation qualification to managing preventative maintenance and calibrations, to overseeing unplanned maintenance activities.  The QC Specialist will interact with Atara QC, Facilities, and Validation, as the laboratory equipment point of contact for Atara QC. 

 

This position is expected to carry out all their activities in compliance with Atara’s Quality processes, the requirements of the Quality Management System, and in compliance with regulation requirements governing laboratory testing and manufacturing.  The ideal candidate demonstrates technical breadth to support equipment management in a laboratory environment. Individuals in this role are very independent, well organized, self-motivated, and are expected to communicate effectively.  In addition, role models the Atara TRAIT values of Transparency, Respect, Accountability, Integrity, and Trust.

 

  

Reports to                      Associate Director, Quality Control

Work Location                Thousand Oaks, CA

 


PRIMARY RESPONSIBILITIES

  • Establish a system for tracking and trending planned and unplanned equipment maintenance activities.
  • Point of contact for unplanned maintenance activities and oversees required servicing.
  • Responsible for preventative maintenance to ensure schedules are maintained, planned, and performed within the required timelines.
  • Recommends, implements, and evaluates laboratory equipment maintenance policies, procedures, methods, and standards to increase overall reliability and implementation of laboratory equipment.
  • Evaluates the need for external contract arrangements with vendors/manufacturers.
  • Maintains an up-to-date library of required service manuals and technical update sheets.
  • Ensures the equipment is maintained cost effectively and in accordance with the manufacturer’s recommended practice and that equipment under warranty is managed within the manufacturer’s warranty.
  • Investigates deviation events related to equipment in the QC areas.
  • Serves as the record owner for change controls required for new and existing QC laboratory equipment. Works with cross-functional teams and the Change Control Board to ensure change records are properly defined, assessed, planned, implemented, reported, and tracked.
  • Support regulatory inspections and audits.

  • Bachelor’s degree in a technical or scientific discipline, with at least 5 years of experience or an equivalent combination of education and experience.
  • Minimum 3 years in a laboratory environment supporting cGMP areas.
  • Minimum 3 years of relevant experience with managing equipment.
  • Basic knowledge of laboratory equipment.
  • Prior experience working within a laboratory equipment asset management system.
  • Prior experience with Quality Management Systems (Deviation, CAPA, Change Control), and/or Equipment Validation.
  • Strong communication skills (written and verbal).
  • Self-motivated, flexible & creative, able to prioritize, multi-task and work in a fast-paced & demanding environment.
  • Role model for Atara TRAIT values (Transparency, Respect, Accountability, Integrity, Trust).

We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We are considered a leading off-the-shelf T-cell immunotherapy company (Nasdaq ATRA) developing novel treatments for patients with cancer, autoimmune and viral diseases.

 

We’re proud of our team of 425+ Atarians co-located by design in 4 different locations including South San Francisco (corporate headquarters), Thousand Oaks (R&D and manufacturing headquarters), Zug, Switzerland (european headquarters) and a R&D site in the Denver, Colorado area. Our Southern California hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility.  

Our mission – “Transform the lives of patients with serious medical conditions through pioneering science, teamwork, and a commitment to excellence.”

 

Our vision - “T-Cell Immunotherapy for every patient, any time.”

 

Atara offers a competitive benefits packages that includes medical/dental/vision benefits, life and disability, retirement and stock program, as well as a generous paid time off and wellness plan that supports the well-being of our staff.  Visit www.atarabio.com/careers to learn more.


Atara Bio is an equal opportunity employer and makes employment decisions on the basis of merit and other lawful factors. In accordance with applicable law, the Company prohibits discrimination based on race, color, religion, creed, sex, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity, expression or dysphoria, marital status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, veteran status, caregiver status, sexual orientation, transgender status or any other classification protected by federal, state or local laws or because of the individual’s association with a member of a protected group or connection to an organization or group related to a protected group.

We comply with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Atara Bio in the United States.
 
 

Keywords: Atara Biotherapeutics, Inc., Thousand Oaks , QC Specialist Operations, Other , Thousand Oaks, California

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