At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.
Position Summary
We are seeking an individual with cell therapy quality control background to join our Quality team. You will contribute to the advancement of our product pipeline by performing environmental monitoring, lot release testing and other assigned tasks. You will also be expected to independently organize, analyze results, and present conclusions. You will ensure that the QC Microbiology Laboratory is operating as expected.
Responsibilities
Conduct routine and non-routine microbiological tests, including but not limited to environmental monitoring, sterility testing by BACT and compendial, bioburden testing, endotoxin testing, and microbial identification. routine environmental monitoring (EM) in GMP manufacturing areas, Aseptic gowning, growth promotion tests and Mycoplasma Testing (qPCR method MycoSEQ).
Participate in the development, validation, and implementation of new microbiological methods, Environmental Monitoring Performance Qualification (EMPQ).
Ensure the QC microbiology laboratory is well-maintained, including equipment calibration, validation, and maintenance. Manage laboratory supplies and inventory.
Analyze microbiological data, ensuring accuracy and compliance with established standards. Maintain detailed and accurate records of all testing and results. Initiate and participate in EM excursion and out of specification (OOS) investigations.
Author or review QC Micro test results and Standard Operating Procedures (SOP).
Conduct investigations into microbiological out-of-specification results, deviations, and other quality issues. Develop and implement corrective and preventive actions (CAPAs).
Work with cross-functional teams, including Manufacturing, Quality Assurance, and R&D, to support ongoing projects and ensure quality standards are met.
Perform other duties as requested by supervisor/manager to support the quality team.
Education and Experience
5+ Years with High School; 2+ Years with BS/BA; 1+ Years with MS/MA specific to microbial contamination and controls.
Demonstrated knowledge of regulatory guidance and industry best practices
Strong knowledge in several of the following areas of competency: aseptic processing, clean room and contamination control, environmental monitoring microbiological methods and cleaning validation.
Knowledge of Microbiology principles, theories, concepts and laboratory methodologies.
Must demonstrate effective organizational skills and ability to manage multiple projects.
Must have demonstrated experience analyzing technical results and summarizing these results in technical reports.
Knowledge of aseptic manufacturing and EM processes.
The annual base salary for this position ranges from $66,883 to $100,. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
DE&I Statement
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
