Posted

7 days ago

Location

Thousand Oaks, CA

Description

Job Description

The QC Learning and Development (L&D) Specialist will help assist in the GMP Training program for Quality Control (QC) at Atara. The QC L&D Specialist builds partnerships with QC management and QC associates to ensure training needs for the team are effectively met and supports the department objectives as directed.  

 

This position reports to the Associate Director, QC. This position is expected to have intermediate knowledge of FDA regulations concerning Good Manufacturing Practices (GMP) to ensure compliance to quality standards for documentation, training, and records management.

 

The ideal candidate demonstrates technical breadth to support analytical test methods in a multi-product clinical phase cellular therapy company that is transitioning toward commercial phase. The candidate will also have demonstrated the ability and desire to train, coach and mentor other analysts. Individuals in this role are very independent, well organized, self-motivated, and are expected to communicate effectively.  In addition, role models the Atara TRAIT values of Transparency, Respect, Accountability, Integrity, and Trust.

PRIMARY RESPONSIBILITIES

  • Develop and deliver instructor led QC specific training for GMP staff
  • Develop and deliver OJT, train other analysts on how to deliver OJTs, and measure proficiency against OJT standards
  • Review deviations for trends and develop training for continuous improvements
  • Partner with GMP L&D team to build tools and reports to assess competency and track qualification
  • Manage QC curriculum development and partner with LMS Administrators for maintenance
  • Develop training on new equipment as required
  • Monitor training metrics for the department and make recommendations to management for corrective actions
  • Assist with internal audits
  • Assist with ongoing continuous improvement of LMS (CW)
  • Prepare oral and written communications to management with clarity and accuracy

Qualifications

  • Bachelor’s degree in Biochemistry, Microbiology, Molecular and Cellular Biology, or Biology with at least 5 years of experience or an equivalent combination of education and experience
  • A minimum of 3 years of relevant experience with Training and Document Management
  • A minimum of 3 years working in an GMP environment
  • Working knowledge of Sharepoint desired
  • A minimum of 3 years’ experience working within a GxP regulated environment preferred
  • 3 years hands-on experience working as an analyst
  • Strong communication skills (written and verbal)
  • Facilitation, coaching or mentoring skills
  • Self-motivated, flexible & creative, able to prioritize, multi-task and work in a fast-paced & demanding environment
  • 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.