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Sr. QC Associate, Microbiology

Employer
Atara Biotherapeutics
Location
San Miguel, Colorado, US
Salary
Competitive
Closing date
Dec 18, 2021

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Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Biology
Salary Type
Salary
Employment Type
Full time
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Job Description The Sr. QC Associate, Microbiology supports manufacturing and technical operations by routinely evaluating the state of control of various manufacturing spaces with an emphasis on special projects for Environmental Monitoring and Microbiology. The Sr. QC Associate is responsible for training, support, and closure of investigations, CAPAs, and CRs. The Sr. QC Associate is responsible for leading projects in support of various studies in QCM and thus expected to have technical writing skills to write investigations and reports. The Sr. QC Associate works within the Atara QC group and is expected to interact regularly and effectively with Manufacturing, Facilities, and Quality Assurance personnel. The Sr. QC Associate is also responsible for performing various EM sampling when required, writing new SOPs, gathering data for quarterly reports and leads new microbiology method enhancements. Additionally, the selected individual performs microbiological laboratory assays as needed with focus on environmental monitoring, growth promotion testing, endotoxin testing, sterility testing, gram staining, bacterial culture, and ID. Reports to: Director, QC MicrobiologyLocation: Thousand Oaks, CATravel: Less than 10%Shift: This role will support a 4 day/10hour work schedule. Either Sunday - Wednesday or Wednesday - Saturday shifts. The shift schedule will be discussed in more detail during the interview process. Primary Responsibilities: * Supports the special projects related to environmental monitoring program. This includes writing technical reports for studies. * Supports the implementation, and execution of a personnel monitoring program. * Supports the implementation and execution of all media fill/process simulations. * Participates in Aseptic Process training for manufacturing, facilities, and quality personnel. * Participates in the validation and technical transfer of microbiological assays (endotoxin, and sterility testing). * Performs routine testing in support of all facility and process qualifications as needed. * Writes investigation reports, new SOPs, and supports writing of quarterly reports including data review. * Reviews EM LIMS reports and Desigo Reports in support of Manufacturing. * Supports internal and external inspections and audits. * Works with QA to investigate quality events, performs root cause analysis, and implements solutions. * Authors study protocols and study reports, new SOPs. * Trains new personnel in performing EM and other Microbiology method. Qualifications * Bachelor's Degree in Microbiology, Molecular and Cellular Biology, Biochemistry, or Biology * 4+ years' experience in Quality or Quality Control pharmaceutical or biotech industry supporting cGMP manufacturing including site qualification and process validation preferred. * Experience in environmental monitoring, personnel monitoring, sterile gowning, and aseptic process control in accordance with ICH, USP and FDA guidelines. * At least 1-year experience in writing EM related reports (deviation or quarterly or study reports) * Experience participating and supporting regulatory inspections through explanations of methodologies, investigations, and/or laboratory systems. * Independent decision-making capability and ability to think conceptually and understand impact of decisions. * Experience with sterile gowning, working in controlled environments, and knowledge of ISO, FDA, USP, and EU GMP regulations. * Must possess excellent verbal and written communication skills, good interpersonal skills. * Emerging leadership and mentoring experience desired. * Experience in cGMP for media suitability, bioburden, endotoxin, and sterility testing is a plus. * 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.

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