Analyst 1, QC Microbiology

Fujifilm•Holly Springs, NC

5d•Onsite

About The Position

The Analyst 1, QC Microbiology performs microbial testing in the QC Microbiology laboratory for in-process drug substance, drug product, environmental and utility monitoring, and raw materials samples, in accordance with written procedures and with minimal supervision. The role supports environmental and utilities monitoring sample collection, testing logistics, and the availability of laboratory materials and supplies. The Analyst conducts microbiology testing and reviews and interprets results, including Bioburden, Endotoxin, sterility, and microbial findings. The position also supports validation and qualification work, including isolator qualification, routine operations, and maintenance. It contributes to laboratory data management, audit readiness, troubleshooting, continuous improvement, CAPA and deviation resolution, project execution, and training and onboarding of new staff as needed. The position is based at FUJIFILM Biotechnologies’ Holly Springs, North Carolina facility. The facility supports a 24/7 manufacturing operation, and the employee must be flexible to support it. The work includes laboratory activities and the physical demands described in the posting.

Requirements

Bachelor’s degree in a scientific discipline.
0–1 years of experience.
Basic understanding of GMP, GLP, and GDP requirements.
Excellent attention to detail, basic technical writing and problem-solving skills, and strong verbal and written communication skills.
Ability to manage and complete tasks according to a structured plan, work independently with occasional supervisory guidance, and support laboratory audit readiness.
Ability to plan work systematically, adapt to change, and pursue continuous improvement.
Knowledge of basic sciences and microbiology laboratory methods and procedures.
Ability to work cross-functionally with a diverse team, collaborate with junior team members, and quickly learn procedures and practices in the assigned area.
Familiarity with fundamental statistical tools for analyzing data and trends.
Basic understanding of data-management systems such as Trackwise or LIMS, or ability to learn their basic use and navigation.
Ability to learn and incorporate lean laboratory and Six Sigma principles into daily work.
Flexibility to support a 24/7 manufacturing facility.
Ability to meet the listed physical demands, including discerning audible cues; performing tasks with 20/20 corrected vision and distinguishing color; ascending or descending ladders, scaffolding, or ramps; standing and sitting for up to 60 minutes; repetitive wrist, hand, or finger motions; moving objects up to 10 pounds; and bending, pushing, pulling, reaching, and twisting.
Work in an environment operating a motor vehicle or Powered Industrial Truck.

Nice To Haves

Bachelor’s degree in Microbiology, Chemistry, Biochemistry, or Biology.
Two or more years of intermediate experience in a GMP QC Microbiology laboratory.
Knowledge of compendial test methods, including Bioburden, Endotoxin, and sterility testing.
Ability to troubleshoot and maintain laboratory equipment and instrumentation.
Experience with microbial identification systems such as MALDI or MicroSeq.

Responsibilities

Support environmental and utilities monitoring sample collection.
Provide input on sample-collection and logistics protocols to ensure regulatory compliance.
Coordinate testing materials and supplies; plan for and ensure materials are stocked.
Partner with procurement, inventory management, and distribution to optimize laboratory operations.
Perform microbiology testing and generate complex test data for in-process samples, raw materials, and environmental samples, including analysis of Bioburden, Endotoxin, and microbial findings.
Perform sterility testing and validation processes, and participate in isolator qualification procedures and routine operations and maintenance.
Ensure accuracy and security of laboratory information by implementing data-management tools and protocols.
Review laboratory testing results and analyze and interpret results, identify trends, and make recommendations.
Troubleshoot laboratory assay issues under management direction, identify causes of assay failures, and develop solutions to improve test reliability.
Lead general laboratory support and maintenance initiatives, including maintaining analytical instruments and laboratory resources and coordinating purchases and receipt of supplies.
Support implementation and monitoring of CAPAs.
Partner with management to initiate and coordinate resolution of deviations and non-conformance events within quality systems.
Participate in project development from concept through execution, ensuring alignment with organizational goals.
Assist with document preparation and review, project timelines, qualification and validation protocols, and training and onboarding of new staff as needed.
Perform additional duties as needed.