Atara Biotherapeutics, Inc. QC Associate in Thousand Oaks, California
The QC Associate, Microbiology supports manufacturing and technical operations by routinely evaluating the state of control of various manufacturing spaces with an emphasis on Environmental Monitoring. The QC Associate is responsible for collecting viable and non-viable particulate samples in classified controlled environments. This person works within the Atara QC group and will interact regularly with manufacturing, facilities, and quality assurance personnel.
Additionally, perform microbiological laboratory assays as needed with focus on endotoxin testing, sterility testing, gram staining, media suitability and purity testing. The Associate also supports the training for Aseptic Operator’s Qualification and Gowning Qualification at ATOM Manufacturing Facility.
Reports to: Director, QC Microbiology
Location: Thousand Oaks, CA
Travel: Less than 10%
Shift: This role will support a 4 day/10-hour work schedule. Either Sunday – Wednesday or Wednesday – Saturday shifts.
Supports the routine and non-routine environmental monitoring program.
Supports personnel monitoring program including Gowning Qualification and Aseptic Operator’s Qualification.
Supports the implementation and execution of all media fill/process simulations.
Supports Aseptic Process training for manufacturing, facilities, and quality personnel.
Participates in the performance of microbiological assays (endotoxin, and sterility testing, growth promotion and purity testing).
Performs routine testing in support of all facility and process qualifications.
Supports internal and external inspections and audits.
Generates Desigo reports for non-viable particulates testing
Performs Carbon Dioxide Monitoring
Tracks and support the calibration of EM equipment such as Climet and SAS.
Trouble shoot problems with Ultra Tape printers
Generates Work Orders on equipment and non-routine MFG support
Sends isolates for microbial identification
Performs sanitization of Equipment
Performs special projects as assigned
Support revision of SOPs and upload of documents to Veeva.
Trains personnel on gowning.
Bachelor’s degree in Microbiology, Molecular and Cellular Biology, Biochemistry, or Biology or an equivalent combination of education and experience.
Quality control experience in the pharmaceutical industry supporting cGMP manufacturing including site qualification and process validation preferred.
Direct experience in environmental monitoring, personnel monitoring, sterile gowning, and aseptic process control in accordance with ICH, USP and FDA guidelines, preferred.
Experience with regulatory inspections.
Independent thinker and ability to understand impact of decisions.
Excellent verbal and written communication skills, good interpersonal skills.
Experience in cGMP for cell therapy testing is a plus.
Able to work in controlled environments requiring special gowning.
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.
Job ID: 2021-1557
External Company Name: Atara Biotherapeutics, Inc.
External Company URL: https://www.atarabio.com/