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.
Job DescriptionResponsibilities:
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 assigned
Requirements:
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)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 facility
Preferred Experience:
1-2 years of CGMP laboratory experience
Working Environment:
Ability to stand for prolonged periods of time up to 60 to 120 minutesAbility to sit for prolonged periods of time up to 60 to 120 minutesAbility to conduct activities using repetitive motions that include wrists, hands and/or fingers.Ability to operate machinery and/or power tools.Ability to conduct work that includes moving objects up to 10 pounds.Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.
Environmental Conditions:
Will work in warm/cold environments (2-8 C Range)
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
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