Quality Control Associate, Microbiology

FUJIFILM Diosynth Biotechnologies•Thousand Oaks, CA

27d•$31 - $39•Onsite

About The Position

The QC Associate, Microbiology is responsible for executing microbiology activities to support Quality Control, Facility, and Manufacturing operations, which include Environmental Monitoring Performance Qualification (EMPQ) and GMP utilities qualification. The QC Microbiology Associate will be responsible for performing environmental monitoring, personnel monitoring, and microbiological testing to ensure compliance with industry standards and regulations. The successful candidate will work closely with the Quality Control team to support the production process and ensure product quality. Additionally, this position supports on-site activities related to sample management. At FUJIFILM Biotechnologies California, we're driving the future of medicine with the expertise to produce life-changing cell therapies like T-cell and CAR T immunotherapies. Working with pioneering biotech partners, our teams manufacture innovative treatments that improve lives. Join us at our advanced Thousand Oaks facility, where you'll make a tangible impact on groundbreaking therapies. We offer a collaborative, flexible workplace and a vibrant culture driven by passion and energy-what we call Genki. If you're ready to reimagine the future of healthcare, let's create something extraordinary together. Our campus is in Thousand Oaks, California, an exceptional place to live with great schools, natural beauty, outdoor activities, and proximity to Los Angeles and Santa Barbara. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: https://www.fujifilm.com/us/en/about/region/careers

Requirements

Bachelor's degree in microbiology, Molecular and Cellular Biology, Biochemistry, or Biology with 0-3 years of experience; or Associate degree with 4+ years of direct laboratory experience; or High school diploma with 6+ years of experience
Quality Control experience in the pharmaceutical industry supporting cGMP manufacturing including site qualification and utility validation preferred.
Direct experience is highly desirable in environmental monitoring, personnel monitoring, sterile gowning, and aseptic process control in accordance with ICH, USP and FDA guidelines.
Direct experience is highly desirable in regulatory inspections.
Must possess excellent verbal and written communication skills, good interpersonal skills.
Experience in cGMP for cell therapy testing is a plus.
Must be able to work in controlled environments requiring special gowning
Subject to extended periods of sitting and/or standing in a laboratory and classified room environment.
Ability to lift 50 lbs. and to work in controlled space laboratory required.
Ability to use ladders to reach high sampling sites
Ability to reach above the shoulder and bend to be able to gown
Work is performed in a laboratory environment and includes use of LN2 freezers and lifting/movement of racks of sample boxes
This role will support either 4-day, 10-hour work schedule OR a 5-day, 8-hour work schedule.
This role requires working in a flexible and dynamic environment, and it may be necessary to shift work schedules, or work overtime, as needed.

Nice To Haves

Quality Control experience in the pharmaceutical industry supporting cGMP manufacturing including site qualification and utility validation preferred.
Direct experience is highly desirable in environmental monitoring, personnel monitoring, sterile gowning, and aseptic process control in accordance with ICH, USP and FDA guidelines.
Direct experience is highly desirable in regulatory inspections.
Experience in cGMP for cell therapy testing is a plus.

Responsibilities

Conduct environmental monitoring of controlled areas (e.g., clean rooms).
Collect samples from non-viable air, viable air (active and passive), surface monitoring, and personnel monitoring to support routine environmental monitoring, in-process environmental monitoring, process simulation, aseptic operator qualification and gowning qualification.
Performs sampling and testing of GMP utilities such as compressed gases.
Perform microbiological testing.
Ensure all tests are completed in accordance with SOPs and regulatory guidelines.
Conduct routine cleaning and maintenance of laboratory equipment to ensure optimal performance.
Keep detailed records of equipment maintenance activities and schedules.
Generate work orders for equipment servicing and repairs, as needed.
Ensure laboratory cleanliness and compliance with safety standards.
Properly handles, stores, and disposes of hazardous materials according to site procedures.
Coordinates the shipping of isolates for microbial identification
Performs any combination of sample management tasks, including label, prepare for shipping, transfer to labs, inventory, and disposal.
Accurately record and manage all test results and data.
Document execution and data using LIMS or forms.
Reviews and verifies sample documents against samples to ensure accuracy and communicate discrepancies. Distributes sample information and documents
Maintain databases for tracking trends and ensuring data integrity.
Generate reports and communicate findings to relevant stakeholders.
Performs document management tasks for sample documents and logbooks, such as uploading of data reports/data packets into the document management system (Veeva).
Ensure compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
Support internal audits and regulatory inspections.
Assist in the review and revision of SOPs related to microbiology testing.
Participate in continuous improvement initiatives within the Quality Control department.
Identify areas for process optimization and implement changes accordingly.
Performs special projects as assigned.