Sr. Specialist QC Operations

Job Locations US-CA-Thousand Oaks
ID
2020-1315
Category
Quality
Type
Regular Full-Time

Job Description

The Senior Specialist QC Operations position, supports Manufacturing and Technical Operations by building and overseeing the control, receipt, and distribution of all test samples, sample retention, reference samples, and stability samples.  The Senior Specialist QC Operations position interacts regularly with Atara’s Manufacturing, QC Analytical, and Translational Sciences groups as well as Atara’s external CMO and test laboratories. Additionally, the selected individual oversees and manages product and raw material sample transfers and track testing at all external contract testing laboratories. Work on LIMS system as a User to support sample management. This position supports the qualification and validation of all QC sample management programs and activities necessary to qualify our new Thousand Oaks cell therapy manufacturing facility.


Reports to
               Senior Manager, Quality Control (QC)

Location                  Thousand Oaks (NW Los Angeles area), California 


Primary Responsibilities

  • Supports the set up and qualification of a GMP compliant QC sample receipt, retain, and distribution system
  • Builds and leads a team of QC associates to manage sample receipt, retain, and distribution
  • Authors, reviews, approves, and executes method and program SOPs.
  • Familiarity with handling stability samples and understanding of stability study design.
  • Serves as QC Sample Management subject matter expert during internal and external inspections and audits.
  • Experience working on Quality System records (Deviations, CAPAs, Change Controls) in Veeva. Provide guidance on investigations
  • Complete CAPAs and close records in Veeva
  • Triage, delegate and manage the high priority issues from cross-functional leads.
  • Attend the Work Center Team (WCT), Deviation Triage WCT, Materials WCT, facilities WCT meetings to discuss ongoing work and issues escalations.
  • Workflow development and optimization for MFG sample Chain of Custody, QC Sample management, QC Contract Lab Data Management, Retain Strategy
  • Works with CMOs to implement sample retain management system.
  • Work as a LIMS User to support the LIMS Lot Sample Management function.
  • Create/Approves Lots in LIMS, Log Samples, Print Labels, Oversee samples assignment to Quality Control Analytical team for testing.
  • Manages all sample shipments to and from Atara and the raw material contract testing labs. Manages the flow of QC data from testing labs: interfaces with the QC LIMS administrator to ensure timely delivery and availability of authorized data from contract labs to Atara LIMS system.
  • Establishes routine operations to govern activities in the QC sample management. Routine activities include scheduling sample shipments, ordering supplies, overseeing equipment maintenance and calibration, performing documentation reviews, and escalating any issues appropriately.

 Travel     Up to 20%

 

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Qualifications

Education and Professional Experience

  • Requires a Bachelor’s Degree in Biochemistry, Microbiology, Molecular and Cellular Biology, or Biology with at least five years of experience or an equivalent combination of education and experience.
  • Quality control experience in the pharmaceutical industry supporting cGMP areas, including sample and stability program management.
  • Experience leading people and/or projects with history of achieving results and outstanding outcomes.
  • Seven (7) years or more experience.

 Position Requirements

  • Experience implementing and overseeing sample management programs.
  • Experience with stability samples management.
  • Experience working on LIMS system.
  • Experience participating and/or supporting regulatory inspections.
  • Experience working in Laboratory environment, handling equipment’s/freezers.
  • Strong critical thinking and decision-making abilities required.
  • Advanced knowledge of relevant regulations and FDA guidance.
  • Strong conflict resolution and negotiation skills required.
  • Proven project management skills required. Must possess strong organizational skills with demonstrable positive results managing multiple projects.
  • Must possess excellent verbal and written communication skills, good interpersonal skills.
  • Emerging leadership and mentoring experience required. Must be able to lead and inspire others.
  • Experience in a cell/gene therapy cGMP manufacturing and testing facility is a plus.
  • Flexibility to travel as required to accommodate the needs of the business.
  • Must be able to work in controlled environments requiring special gowning for biosafety and radiation laboratories.
  • Role model for Atara Bio values.

More about Atara Bio

We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We’re named after Atara Ciechanover who suffered from cancer before passing away. 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 350+ Atarians co-located by design in South San Francisco (corporate headquarters) and Southern California (R&D and manufacturing headquarters in the northwest Los Angeles area) with a newly-established European headquarters in Zug, Switzerland. Atara also has a R&D site in the Denver, Colorado area and an office in New York City. 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 in Thousand Oaks, California.

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.”

 

Visit www.atarabio.com 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.
 
 

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