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Quality Associate -Supply Chain QA

Company: Atara Biotherapeutics
Location: Thousand Oaks
Posted on: June 8, 2021

Job Description:

Job Description

The Quality Associate/Senior Associate-Supply Chain QA role supports GMP material receipt, distribution and manufacturing processes on the floor by providing Quality Assurance oversight. The successful candidate is proficient in communication (written and verbal), multitasks across multiple functional areas, is timeline focused and flexible in in their work scheduling to meet the demands of a multi-product clinical phase cellular therapy company that is transitioning to the commercial phase.

Reports to Associate Director, QA

Location Thousand Oaks, CA

Travel May be required (up to 10%)

Primary Responsibilities:

  • Works with moderate supervision and direction.
  • Supports GMP material receipt, stock transfer, distribution and label insurance and inspection.
  • Communicates cross-functionally to ensure on-time release of material.
  • Participates in determining objectives of assignments.
  • Performs real time documentation (batch record, logbook, etc.) review concurrent with manufacturing operations on the manufacturing floor.
  • Participates in routine quality audits of warehouse and manufacturing operations.
  • Reviews and assesses quality system information (i.e. alarm reports, work orders).
  • Supports quality systems related to QA for in-process sampling and controls, and all aspects of shop floor QA.
  • Acts as the Quality representative on the floor during manufacturing operations and troubleshooting.
  • Investigates minor non-conformances within warehousing and production areas using knowledge of manufacturing process, utilities, and equipment.
  • Participates in cross-functional team meetings to resolve minor non-conformance and CAPA issues.
  • Performs activities related to change controls.
  • Cross trains within the area of Batch Review and Release.
  • Drafts and revises SOPs, Work Instructions, and other controlled document types.

Qualifications

  • Bachelor's Degree in Engineering or Life Sciences.
  • GMP regulated Biologics or Pharmaceutical environment or Related Pharmaceutical or Biotech industry experience preferred
  • Root Cause Analysis Training preferred
  • Ability to work as part of a team, demonstrating excellent communication and interpersonal skills
  • Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines
  • Strong problem solving and analytical skills with demonstrated ability to be detail oriented
  • Experience in 21 CFR 210/211, 1271 and 810 preferred
  • Ability to gown and gain entry to manufacturing areas
  • Flexibility in working schedule, i.e., off hours, second shift and weekends
  • Role model for Atara TRAIT values (Transparency, Respect, Accountability, Integrity, Trust)

More about Atara Bio

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, Thousand Oaks , Quality Associate -Supply Chain QA, Other , Thousand Oaks, California

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