Associate 1, Quality Control Microbiology

Fujifilm • Morrisville, NC

55d • Onsite

About The Position

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.

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

Nice To Haves

• 1-2 years of CGMP laboratory experience

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 501-1,000 employees