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Associate/Senior Associate- Supply Chain QA (Labeling and Packaging)

Company: Atara Biotherapeutics
Location: thousand oaks
Posted on: May 3, 2021

Job Description:

Job Description

Associate/Senior Associate- Supply Chain QA (Labeling and Packaging)

This role supports label insurance and inspection, provides QA oversight to Supply Chain operations including labeling and packaging, GMP material receipt, and stock transfer. The successful candidate is proficient in communication (written and verbal), multitasks across multiple functional areas, is timeline focused and flexible in their work scheduling to meet the demands of a multi-product clinical phase cellular therapy company that is transitioning to the commercial phase.Reports to: Associate Director, QA

Location: Thousand Oaks (NW Los Angeles area), CA

Travel: may be required (up to 10%).

Primary Responsibilities:

* Works with moderate supervision and direction. * Supports label insurance and inspection for primary and secondary labels. * Provides QA oversight to Supply Chain operations, including labeling and packaging, GMP material receipt, and stock transfer * Performs real-time documentation (batch record, logbook, etc.) review concurrent with Supply Chain operations on the floor. * Organize, prioritize, and plan daily activities to meet the on-time label insurance, just-in-time labeling and packaging and stock transfer operations. * Participates in routine quality audits of Supply Chain operations. * Reviews and assesses quality system information (i.e. alarm reports, work orders) related to Supply Chain operations. * Acts as the Quality representative on the floor during Supply Chain operations and troubleshooting. * Investigates minor non-conformances within warehousing and labeling and packaging areas using knowledge of the process, utilities, and equipment. * Participates in cross-functional team meetings to resolve minor non-conformance and CAPA issues. * Performs activities related to change controls related to Supply Chain operations. * Cross trains within the area of batch review and release of materials and final packaged products. * Drafts and revises SOPs, Work Instructions, and other controlled document types.

Qualifications

* Bachelor's Degree in Engineering or Life Sciences * Previous GMP regulated Biologics or Pharmaceutical environment preferred * Related Pharmaceutical or Biotech industry experience preferred * Root Cause Analysis Training preferred * Strong knowledge in 21 CFR 210/211, 1271 and 810 preferred * Ability to gown and gain entry to manufacturing areas * Ability to work as part of a team, demonstrating excellent communication and interpersonal skills * Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines * Strong problem solving and analytical skills with demonstrated ability to be detail oriented * Flexibility in working schedule, i.e., off hours, second shift and weekends * 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 , Associate/Senior Associate- Supply Chain QA (Labeling and Packaging), Other , thousand oaks, California

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