The Associate 1, Quality Control (QC) Microbiology is an entry level position responsible for performing routine microbiological testing of clean utility, environmental monitoring, and manufacturing batch samples. This role performs routine laboratory testing and support activities and participates in continuous improvement initiatives.
Company OverviewWe are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At FUJIFILM Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.
Job DescriptionPrincipal Accountabilities:
Provides facility support through the collection and testing of site clean utilities (e.g., water, stem, and compressed gases)Performs basic microbiological testing (e.g., Bioburden, Endotoxin, and Growth Promotion) per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batchesReviews laboratory testing results and enters data into the Laboratory Information Management System (LIMS)Performs environmental monitoring of controlled manufacturing environments, as neededEnsures laboratory maintains inspection readiness, data integrity, and Current Good Manufacturing Practice (CGMP) complianceAssists management with technical services, such as initiating events (e.g., deviations and non-conformances) within quality systemsIdentifies and solves problems while consulting and under the direction of managementParticipates in project developments from concept through execution, ensuring alignment with organizational goalsPerforms other duties, as assignedMinimum Education and Experience Required:
High School Diploma/GED with 4 years of Microbiology experience; orAssociate’s degree in Life Science, Pharmaceutical, or related field with 2 years of Microbiology experience; orBachelor’s degree in Life Science or Biology with no previous experienceExperience with data management systems (e.g., LIMS, TrackWise)Prferred Education and Experience:
1-2 years of cGMP laboratory experienceKnowledge, Skills and Abilities:
Knowledge of aseptic techniques and behaviorsEffective communication, both written and verbalBasic technical writing and problem-solving skillsAbility to complete work both independently and under guidance from SupervisionAbility to systematically approach daily tasksAbility to effectively collaborate with coworkers and internal clientsFamiliarity with United States Pharmacopeia and European PharmacopeiaAbility to support audit readiness for the laboratoryWillingness to learn and incorporate lean lab and six sigma principles into the work environmentAbility to manage and complete tasks according to a structured planBasic understanding and familiarity with data management systems, such as TrackWise, LIMS, and capability to learn basic use and navigation within the systemsMust be flexible to support 24/7 manufacturing facilityPHYSICAL REQUIREMENTS
PHYSICAL DEMANDS
Will work in environment which may necessitate respiratory protection. X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. X No Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes
WORKING ENVIRONMENT:
PHYSICAL DEMANDS
Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes
Ability to stand for prolonged periods of time. No X Yes 60-120 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to sit for prolonged periods of time. No X Yes 60-120 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. No X Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. No X Yes
ENVIRONMENTAL CONDITIONS
Will work in warm/cold environments. No X Yes 2-8 C Range (If yes, specify approximate temperature ranges.)
Will work in outdoor elements such as precipitation and wind. X No Yes
Will work in small and/or enclosed spaces. X No Yes
Will work in heights greater than 4 feet. X No Yes
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA InformationIf you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (HR_FDBU@fujifilm.com).
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