Manager, QC Operations Details

Manager, QC Operations

Atara Biotherapeutics, Inc. - Thousand Oaks, CA

Employment Type : Full-Time

Job Description: The Manager, Quality Control Operations position, leads a team of QC associates that executes Sample Management activities including control, receipt, and distribution of product, intermediates, raw materials samples, sample retention, reference samples, and stability samples.

The Manager 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. 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, California

Primary Responsibilities

• Supports the set up and qualification of a GMP compliant QC sample receipt, retain, and distribution system.
• Manages, coaches, and develops team of QC associates.
• Authors, reviews, approves, and executes Sample plans and program SOPs.
• 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.
• Manage and approve Sample management activities in LIMS.
• Manages all sample shipments to and from Atara and the raw material contract testing labs. Receives the testing results from the contract test labs.
• 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.
• Staff management: Scheduling, timesheet approval, invoice approval, issues resolution

Qualifications:

• 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.
• 7+ years of relevant biotech/pharma industry experience.
• 2+ years direct experience supervising/managing direct reports.
• Strong GMP skills.
• Experience leading people and/or projects with history of achieving results and outstanding outcomes.
• Strong communication skills, team player, proven negotiation skills.
• Experience implementing and overseeing sample management programs.
• 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.
• Advanced knowledge of relevant regulations and FDA guidance.
• Strong time and project management 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.
• 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.

Job Type: Full-time