Senior Specialist Quality Assurance, Lot Disposition
Company: Atara Biotherapeutics
Location: Thousand Oaks
Posted on: June 3, 2021
The Senior Specialist Quality Assurance, Lot Disposition, is
responsible for ensuring quality and compliance of product
disposition and to identify and drive continuous improvement. This
role is instrumental in ensuring supply to patients by releasing
material produced at Atara and CMO sites across both Clinical and
Commercial. This position interacts cross-functionally with
Manufacturing, Supply Chain, Regulatory, Clinical Operations,
Quality Control, Process Sciences, and Validation to ensure on time
disposition is met.
Reports to: Director, QA Disposition
Location: Thousand Oaks, CA
- Independently perform and manage batch release activities for
production including, but not limited to, review of batch records,
analytical data, certificates of analysis, and other
- Provides quality oversight of cGMP activities supporting all
material and product disposition including raw material & starting
material receipt and disposition, Viral Vector, drug critical
reagent, drug substance and drug product manufacturing, labeling,
batch record review, and lot disposition.
- Establishes collaborative relationships with internal and
external stakeholders to ensure timely documentations, resolution
of quality issues, and implementation of effective CAPAs.
- Partners with cross-functional teams to ensure products are
delivered on time and within specification.
- Review & approve any major/minor deviations, change proposals
or other quality records, as needed, to support lot
- Perform review and approval of Quality documentation such as,
equipment, system, process, and method validations, qualification
and validation reports, master batch records, validation master
plans (VMPs), change control, risk assessments and technical
- Identify and support continuous improvement projects in
collaboration with different cross functional teams to drive
manufacturing reliability and enhance quality and efficiency.
- Performs other duties as assigned.
- BS degree in life sciences or related field (advanced degree
- 4 years of experience in biopharmaceutical industry (prefer
experiences in both large and small company environments),
experience in batch disposition preferred.
- Experience in Aseptic Processing
- Ability to self-manage and work effectively with internal &
external stakeholders and parties, including regulatory agencies,
with minimal oversight.
- Attention to detail with strong analytical and problem-solving
- Working knowledge of manufacturing and laboratory
- Must possess excellent verbal and written communication skills;
good interpersonal skills.
- 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
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 , Senior Specialist Quality Assurance, Lot Disposition, Other , Thousand Oaks, California
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