Sr. QA Specialist - QA for QC
Company: Atara Biotherapeutics
Location: Thousand Oaks
Posted on: June 13, 2021
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
- 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
- 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
- Review and approve revisions to test methods & forms, work
instructions, SOPs, protocols, and instructional learning
- Support audit readiness projects and new product introduction
- 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
- Perform work that consistently requires independent decision
making and the exercise of independent judgment and discretion with
a "patients first" value system.
- 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
- Advanced knowledge of relevant regulations and regulatory
- Experience in 21 CFR 210/211, 1271, 2001/83/EC, 2006/17/EC and
- Experience with USP and EP compendial testing.
- Experience leading, approving or overseeing laboratory
investigations of Out of Specification and Out of Trend analytical
- 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
- Experience with QA/QC in a cell therapy company.
- Excellent verbal and written communication skills; good
- 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
- Strong problem solving and analytical skills with demonstrated
ability to be detail oriented, while managing multiple projects
- Strong team player and ability to collaborate cross
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
Our vision - "T-Cell Immunotherapy for every patient, any
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
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