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.

Responsibilities:

• 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 batches
• Reviews laboratory testing results and enters data into the Laboratory Information Management System (LIMS)
• Performs environmental monitoring of controlled manufacturing environments, as needed
• Ensures laboratory maintains inspection readiness, data integrity, and Current Good Manufacturing Practice (CGMP) compliance
• Assists management with technical services, such as initiating events (e.g., deviations and non-conformances) within quality systems
• Identifies and solves problems while consulting and under the direction of management
• Participates in project developments from concept through execution, ensuring alignment with organizational goals
• Performs other duties, as assigned

Requirements:

• High School Diploma/GED with 4 years of Microbiology experience; or
• Associate’s degree in Life Science, Pharmaceutical, or related field with 2 years of Microbiology experience; or
• Bachelor’s degree in Life Science or Biology with no previous experience
• Experience with data management systems (e.g., LIMS, TrackWise)
• Knowledge of aseptic techniques and behaviors
• Effective communication, both written and verbal
• Basic technical writing and problem-solving skills
• Ability to complete work both independently and under guidance from Supervision
• Ability to systematically approach daily tasks
• Ability to effectively collaborate with coworkers and internal clients
• Familiarity with United States Pharmacopeia and European Pharmacopeia
• Ability to support audit readiness for the laboratory
• Willingness to learn and incorporate lean lab and six sigma principles into the work environment
• Ability to manage and complete tasks according to a structured plan
• Basic understanding and familiarity with data management systems, such as TrackWise, LIMS, and capability to learn basic use and navigation within the systems
• Must 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 minutes
• Ability to sit for prolonged periods of time up to 60 to 120 minutes
• Ability 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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