Analyst, QC Microbiology (2-2-3, 0600-1800)

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 6 days ago

Vacancies: 1 Vacancy

Department:

Quality Control

Job Summary

Position Overview

The QC Analyst is responsible for the key operational aspects of the QC Microbiology laboratory. Incumbent will perform microbial testing of all in -process drug substance drug product EM/UM and raw materials samples. Incumbent will be responsible for all associated activities associated with this testing in accordance with written procedures. This position primarily works under minimal supervision as needed. This position will initially be involved in the commissioning activities involved in the construction of a new Biopharmaceutical manufacturing facility and laboratory. Flexibility in job roles and assignments will be required. This may include writing or assisting with document preparation and review managing project timelines conducting qualification and validation protocols and assisting management with training and on-boarding of new staff as needed and in addition to regular work duties and assignments.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were looking for passionate mission-driven people to help us realize this exciting vision and deliver the next vaccine cure or therapy. We offer a dynamic work environment and were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 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: Description

What Youll Do

Collects samples for Environmental monitoring (EM) and Utilities monitoring (UM). Responsible for all sample collection and logistics as needed.
Coordinates testing materials and supplies needed for testing
Performs Basic Microbiology laboratory testing following standard procedures for all samples including but not limited to all in-process samples raw materials EM and utilities samples for Bioburden Endotoxin plate reading and microbial identification
Performs sterility testing isolator qualification and routine operations and maintenance
Sample and data entry into LIMS system
Reviews general lab testing results
Troubleshoots routine assays
General laboratory support and laboratory maintenance in a cGMP laboratory including maintaining laboratory supplies needed for operations maintenance of analytical instruments purchasing and receiving of laboratory supplies (media kits etc.)
Ensures CAPAs are being followed in the laboratory areas
Notifies management and assists with the initiation of events (such as deviations) in the quality systems
Assists with projects as assigned

Works 12-hour shift on 2-2-3 cadence 0600-1800
Performs other duties as assigned

Minimum Requirements:

BA/BS in scientific discipline
0-2 years of basic GLP laboratory experience
Understanding of GMP GLP GDP requirements
Knowledgeable in basic sciences and Microbiology laboratory methods and procedures

Basic LIMS training

Preferred Requirements:

BS within Microbiology Chemistry Biochemistry Biology
2 years of Intermediate experience in a GMP QC Microbiology Laboratory knowledge of all compendial test methods (Bioburden
Endotoxin sterility testing) preferred
Ability to troubleshoot and maintain laboratory equipment and instrumentation
Experience with microbial ID systems (MALDI MicroSeq)

Intermediate LIMS training
Knowledge or training of FDA regulations (cGMP cGLP cGDP)
Trackwise System training
Lean / 6S training

Physical and Work Environment Requirements:

Ability to discern audible cues.

Ability to inspect or perform a task with 20/20 corrected vision visual acuity including distinguishing color.

Ability to ascend or descend ladders scaffolding ramps etc

Ability to stand for prolonged periods of time up to 60 minutes.

Ability to conduct activities using repetitive motions that include writs hands and/or fingers.

Ability to sit for prolonged periods of time up to 60 minutes.

Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions.

Will work in small and/or enclosed spaces.

Will work in heights greater than 4 feet.

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 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.

EEO Information

Fujifilm is committedto 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 Information

If 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 ().

Required Experience:

Position OverviewThe QC Analyst is responsible for the key operational aspects of the QC Microbiology laboratory. Incumbent will perform microbial testing of all in -process drug substance drug product EM/UM and raw materials samples. Incumbent will be responsible for all associated activities assoc...