QC Manager, Microbiology

Employer
Atara Biotherapeutics, Inc.
Location
Thousand Oaks, California, US
Salary
Competitive
Posted
Jun 13, 2021
Closes
Jun 27, 2021
Ref
2249026517
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
The QC Manager, Microbiology provides management and oversight of the QC Microbiology department ensuring that staff are trained and resourced to execute their duties in a reliable and compliant manner supporting in-process testing and environmental monitoring, personnel monitoring, gowning qualification, and utility testing.

This position is also responsible for ensuring adequate resources and oversight of the non-routine method qualification and studies, area requalification, growth promotion and media testing.

Reports to: Director, QC Microbiology

Location: Thousand Oaks, CA

Travel: Less than 10%

Shift: This role will support a 5 day/8-hour work schedule. Either Sunday - Thursday or Tuesday - Saturday or Monday - Friday shifts.

Primary Responsibilities
  • Ensure that EM Data Trending is performed on a timely manner and escalate EM Trends as necessary.
  • Oversee daily microbial testing activities to support the development and manufacture of drug/device products.
  • Manage the environmental monitoring (EM) program, compressed gas monitoring program, gowning qualification, and microbiological testing.
  • Ensure that lab and environmental monitoring activities are conducted according to safety guidelines, policies, and legislation.
  • Review quality documentation of the QC Microbiology Department.
  • Manage alert and action level and other events investigations.
  • Maintain quality and quantity of departmental work through initial and continued training and oversight of lab staff; propose additional or customized training to lab management according to need.
  • Support audits of Microbiology during regulatory inspections.
  • Write/support investigation reports as needed.
  • Write, review, and implement QC protocols for test method qualification/validation, SOPs and other quality processes such as LIMS.
  • Participate in quality testing procedure's development or improvement.
  • Ensure GMP compliance in the QC laboratory; update procedures and improve as needed.
  • Ensure analytical instrument's maintenance and calibration under cGMP regulation.
  • Train QC personnel on quality procedures.
  • Apply knowledge of good manufacturing practices and good laboratory practices daily.
  • Perform GMP audits of laboratories, as appropriate.
  • Note: The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.


Physical Requirements

  • Subject to extended periods of sitting and/or standing in a laboratory environment.
  • Ability to lift 50 lbs. and to work in controlled space laboratory required.
  • Ability to reach above the shoulder and bend to be able to gown.

  • BS/MS degree required. Scientific discipline (i.e., analytical chemistry, microbiology, or related field) preferred.
  • 5+ years' experience in managing a cGMP quality control laboratory.
  • Experience working in a matrix managed team environment and an ability to work effectively with all departments within the company.
  • Ability to maintain detailed and accurate records.
  • Must be highly organized, detail oriented and able to manage multiple projects.
  • Strong written and verbal communication, organization, and prioritization skills.
  • Ability to handle multiple priorities in a project driven environment.
  • Ability to maintain detailed and accurate records.
  • Strong commitment to teamwork, proven leadership skills, independence, and initiative.
  • Proficient in Microsoft Office - Word, Excel, PowerPoint.
  • Comprehensive knowledge of pharmaceutical GLPs and GMPs.
  • Comprehensive knowledge of laboratory techniques and safety precautions.
  • Experience with LIMS software applications is desired.
    Role model for Atara TRAIT values (Transparency, Respect, Accountability, Integrity, Trust).


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.

Similar jobs

Similar jobs