ThousandOaksRecruiter Since 2001
the smart solution for Thousand Oaks jobs

Senior Specialist Quality Assurance, Lot Disposition

Company: Atara Biotherapeutics
Location: Thousand Oaks
Posted on: June 3, 2021

Job Description:

Job Description

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

Responsibilities

  • 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 documents.
  • 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 disposition.
  • 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 reports.
  • 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.

Qualifications

  • BS degree in life sciences or related field (advanced degree preferred)
  • 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 skills
  • Working knowledge of manufacturing and laboratory practices
  • 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 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 , Senior Specialist Quality Assurance, Lot Disposition, 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