QC Associate I, Environmental Monitoring
FUJIFILM Biotechnologies, Milwaukee, WI, United States
Job Summary
The QC Associate I role in Quality Control Microbiology is crucial for performing operational functions of the QC Microbiology laboratory. This position holds the responsibility for conducting environmental and clean utility monitoring and standard microbiological assays, operating under the guidance of laboratory supervisors and lead analysts, and ensuring technical issues are promptly escalated to laboratory management. Tasks will be assigned to off‑shift personnel where possible, and overtime and temporary shift changes may be required to support programs with short testing windows (e.g., bioburden 12‑hours). Major Accountabilities
Supports manufacturing operations through routine environmental monitoring (EM) of classified production areas. Provides facility support by collecting and testing site clean utilities (e.g., water, steam, and compressed gases). Enters data into the Laboratory Information Management System (LIMS). 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 informing and consulting with area management. Partners with laboratory management in scheduling daily, weekly, and non‑routine testing and tasks. Participates in or leads laboratory equipment qualification or validation. Performs other duties as assigned. Knowledge, Skills, and Abilities
Strong working knowledge of aseptic techniques and behaviors. Effective communication, both written and verbal. Technical writing and problem‑solving skills. Ability to aseptically gown into classified manufacturing spaces. Ability to complete work independently with minimal supervision. Ability to prioritize and organize work to deliver assignments according to established schedules and deadlines. Ability to effectively collaborate with coworkers and internal clients. Ability to support audit readiness for the laboratory. Familiarity with United States Pharmacopeia and European Pharmacopeia. 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. Expertise with data management systems, such as TrackWise and LIMS, and capability to learn basic use and navigation within the systems. Must be flexible to support 24/7 manufacturing facility. Minimum Education Requirements
High School Diploma and at least 4 years of laboratory experience in a cGMP environment; or Associate’s degree in Life Science, Pharmaceutical, or related field with at least 2 years of laboratory experience in a cGMP environment; or Bachelor’s degree in Life Science or Biology with no prior experience in a cGMP environment. Preferred Experience
BioWork Certificate. Physical Requirements
Works in an environment that may necessitate respiratory protection. Discerns audible cues. Has 20/20 corrected vision, including color discrimination. Can ascend or descend ladders, scaffolding, ramps, etc. Can stand for prolonged periods of time (240 minutes). Can sit for prolonged periods of time (240 minutes). Conducts activities using repetitive motions that include wrists, hands, and/or fingers. Can move objects up to 33 lbs. Bends, pushes or pulls, reaches to retrieve materials from 18" to 60" in height, and uses twisting motions. Works in warm/cold environments (0-100°F range). Equal Employment Opportunity Statement
Fujifilm is committed to 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.
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The QC Associate I role in Quality Control Microbiology is crucial for performing operational functions of the QC Microbiology laboratory. This position holds the responsibility for conducting environmental and clean utility monitoring and standard microbiological assays, operating under the guidance of laboratory supervisors and lead analysts, and ensuring technical issues are promptly escalated to laboratory management. Tasks will be assigned to off‑shift personnel where possible, and overtime and temporary shift changes may be required to support programs with short testing windows (e.g., bioburden 12‑hours). Major Accountabilities
Supports manufacturing operations through routine environmental monitoring (EM) of classified production areas. Provides facility support by collecting and testing site clean utilities (e.g., water, steam, and compressed gases). Enters data into the Laboratory Information Management System (LIMS). 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 informing and consulting with area management. Partners with laboratory management in scheduling daily, weekly, and non‑routine testing and tasks. Participates in or leads laboratory equipment qualification or validation. Performs other duties as assigned. Knowledge, Skills, and Abilities
Strong working knowledge of aseptic techniques and behaviors. Effective communication, both written and verbal. Technical writing and problem‑solving skills. Ability to aseptically gown into classified manufacturing spaces. Ability to complete work independently with minimal supervision. Ability to prioritize and organize work to deliver assignments according to established schedules and deadlines. Ability to effectively collaborate with coworkers and internal clients. Ability to support audit readiness for the laboratory. Familiarity with United States Pharmacopeia and European Pharmacopeia. 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. Expertise with data management systems, such as TrackWise and LIMS, and capability to learn basic use and navigation within the systems. Must be flexible to support 24/7 manufacturing facility. Minimum Education Requirements
High School Diploma and at least 4 years of laboratory experience in a cGMP environment; or Associate’s degree in Life Science, Pharmaceutical, or related field with at least 2 years of laboratory experience in a cGMP environment; or Bachelor’s degree in Life Science or Biology with no prior experience in a cGMP environment. Preferred Experience
BioWork Certificate. Physical Requirements
Works in an environment that may necessitate respiratory protection. Discerns audible cues. Has 20/20 corrected vision, including color discrimination. Can ascend or descend ladders, scaffolding, ramps, etc. Can stand for prolonged periods of time (240 minutes). Can sit for prolonged periods of time (240 minutes). Conducts activities using repetitive motions that include wrists, hands, and/or fingers. Can move objects up to 33 lbs. Bends, pushes or pulls, reaches to retrieve materials from 18" to 60" in height, and uses twisting motions. Works in warm/cold environments (0-100°F range). Equal Employment Opportunity Statement
Fujifilm is committed to 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.
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