Associate Director, Quality Control

Location
Thousand Oaks, CA
Salary
Competitive Market Pay
Posted
Aug 05, 2019
Ref
1164
Required Education
Bachelors Degree
Position Type
Full time

Position Summary:

The Associate Director, Quality Control supervises, motivates and develops direct reports in accordance with the company’s leadership principles. Plans, coordinates and verifies the proper and timely execution of monitoring activities in the production areas and laboratories. Responsible for the preparation and updating of SOPs governing the environmental monitoring program. Trains all people associated with aseptic activities in general Microbiology techniques and aseptic technique. Provides technical expertise and on the floor mentoring for gowning, disinfection and aseptic technique to manufacturing group

Reports to: Senior Director, Quality Control

Location:  Thousand Oaks, CA

Responsibilities:

  • Coordinates analysts' time, resources, and schedule necessary assays
  • Ensures training in specific assays and sampling rotations
  • Sets, monitors and evaluates goals and performance
  • Develops career paths with analysts
  • Recruits temporary and full-time analysts
  • Reviews the calibration activities for the measuring instruments used in the environmental monitoring group and inspects the relevant log books within the defined intervals
  • Reviews and approves data
  • Assists with assay trouble shooting, failure investigations and improving lab systems
  • Ensures compliant Environmental Monitoring and Utility Monitoring programs are maintained
  • Reviews EM trend data to proactively identify issues
  • Performs sampling rotations or assays as necessary
  • Ensures timely closure of Alert/Action investigations and exception reports
  • Provide SME support on microbiological assays such as Bioburden, Sterility, Endotoxin and Mycoplasma
  • Maintains GMP compliance and documentation
  • Maintains compliance with legal regulations on occupational safety and health, particularly with regard to hazardous materials
  • Implement laboratory policies and procedures
  • Drive lean lab operation, 5S laboratory layout, preventive action & continuous improvement programs to reduce operating costs
  • Lead special projects and investigations as appropriate

Skills & Abilities:

  • Advanced knowledge of microbiology methods and instruments, as apply to aseptic processing. Including validation experience. Advanced knowledge of GMPs, safety regulations and data integrity.
  • Advanced knowledge of GMPs
  • Advanced knowledge of FDA and EMEA requirements
  • Understanding of EPA and OSHA requirements
  • Experience ensuring laboratory KPIs meet compliance requirements
  • Experience ensuring all laboratory investigations meet compliance requirements
  • Advanced knowledge of root cause investigation principles and troubleshooting techniques
  • Application of statistical evaluation of laboratory data
  • Advanced understanding of Laboratory applications (e.g., LIMS, SAP, ATLAS etc.)
  • Advanced knowledge of problem-solving tools (e.g., SPC, Fishbone diagrams, etc)
  • Visual presentation methods & technologies (e.g., design charts, summarize data
  • Application of Lean Laboratory principles
  • Advanced knowledge of microbiology methods used in the laboratory
  • Risk management principles & techniques
  • Experience successfully leading and managing complex project with tight timelines
  • Able to build strong relationships, influence others to desired goal, mentor others

Travel:  Up to 20%

Professional Experience & Education

  • Requires a bachelor’s degree in Biochemistry, Microbiology, Molecular and Cellular Biology, or Biology
  • 10 or more years of experience or an equivalent combination of education and experience
  • Quality control experience in the pharmaceutical industry supporting cGMP areas, including environmental monitoring experience
  • Experience leading people and/or projects with history of achieving results and outstanding outcomes

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 expertise.”

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.