ThousandOaksRecruiter Since 2001
the smart solution for Thousand Oaks jobs

Sr. QA Specialist - QA for QC

Company: Atara Biotherapeutics
Location: Thousand Oaks
Posted on: June 13, 2021

Job Description:

Job Description

This QA Ops support role serves as a lead QA for the three (3) cross-functional teams within Quality Control; Bioanalytical, Operations, and Microbiology. The successful candidate will work with the aforementioned teams, as well as the QC Technical Services team to address on-time closure of deviations, change controls, CAPAs, OOS phase I laboratory investigations, and quality documentation review and approval workflows. In addition, this role will be required to interact with the QA for QC team, QA colleagues (i.e QA for Disposition, QA for Manufacturing, QA for Facilities, QA for IT), Product Quality Leadership (PQL), Analytical Sciences, and Process Sciences.

Reports to: Manager, Quality Assurance

Location: Thousand Oaks, CA

Primary Responsibilities:

  • Collaborate with the QC Technical Services team as well as QC analysts to support on-time closure of major and minor deviations, phase I OOS laboratory investigations, CAPAs, and change controls in accordance with relevant SOPs and audit readiness projects.
  • Attend daily deviation triage for functional areas and provide QA support as needed.
  • Attend weekly QC Technical Services learning and planning huddle.
  • Attend biweekly QA for QC huddles and provide & seek support/updates as needed.
  • Review and approve final and intermediate drug product Certificate of Analysis (CoA) and collaborate with external QA partners to ensure Atara standards by CMOs and CTLs as needed.
  • Review and approve QC method transfer and validation protocols & reports.
  • Review and approve revisions to test methods & forms, work instructions, SOPs, protocols, and instructional learning material.
  • Support audit readiness projects and new product introduction projects.
  • Interface with other departments as needed (e.g., Process Sciences, Analytical Sciences, Manufacturing, Supply Chain, Facilities, Validation, Document Control, Operations, IT) to ensure achievement of Atara's goals, including compliance with all applicable standards.
  • Perform work that consistently requires independent decision making and the exercise of independent judgment and discretion with a "patients first" value system.

Qualifications

  • Bachelor's Degree in Biological Sciences, Microbiology, Molecular & Cellular Biology, or Biochemistry
  • 8+ years of related quality control experience in pharma/biotech supporting cGMP areas.
  • Experience in a commercial phase pharmaceutical environment.
  • Advanced knowledge of relevant regulations and regulatory guidance.
  • Experience in 21 CFR 210/211, 1271, 2001/83/EC, 2006/17/EC and 2006/86/EC.
  • Experience with USP and EP compendial testing.
  • Experience leading, approving or overseeing laboratory investigations of Out of Specification and Out of Trend analytical results.
  • Experience with analytical method qualification, validation, and tech transfer.
  • Strong understanding of Quality Management Systems: deviations, CAPA, Change control etc.
  • Strong independent judgment and decision-making abilities.
  • Advanced knowledge of relevant regulations and guidance's to act as a resource for colleagues.
  • An understanding of T-cell biology and the immunological principles of HLA restriction, and alloreactivity.
  • An understanding of, and experience with, polychromatographic flow cytometry as applied to immunophenotyping.
  • An understanding of, and experience with, cell-based assays.
  • Experience with QA/QC in a cell therapy company.
  • Excellent verbal and written communication skills; good interpersonal skills.
  • Able to work in controlled environments requiring special gowning for biosafety and radiation laboratories.
  • Demonstrate ability to work in a team environment to develop, implement and deliver on goals.
  • Demonstrate ability to work successfully and with appropriate sense of urgency in a nimble fast paced matrixed environment.
  • Ability to work both independently without supervision and be a part of a team, demonstrating excellent communication and interpersonal skills.
  • Strong problem solving and analytical skills with demonstrated ability to be detail oriented, while managing multiple projects simultaneously.
  • Strong team player and ability to collaborate cross functionally.

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 , Sr. QA Specialist - QA for QC, Other , Thousand Oaks, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Thousand Oaks RSS job feeds