Lead QC Associate II
FUJIFILM Biotechnologies, Milwaukee, WI, United States
The Lead QC Associate II role in Quality Control Microbiology is crucial for overseeing and guiding the critical operational functions of the QC Microbiology laboratory. This position holds the responsibility for conducting microbiological assays, and for effectively training junior analysts in these areas. The incumbent will operate largely autonomously, ensuring technical issues are promptly escalated to laboratory management. Overtime and temporary shift changes will be required to support programs that have samples with short testing windows (e.g., bioburden 12‑hours).
Company Overview At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life‑impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you. From our Bioprocess Innovation Center to our cGMP‑compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare. Situated at the cross‑section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities. Fujifilm is globally headquartered in Tokyo with over 70,000 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: https://www.fujifilm.com/us/en/about/region/careers
Job Description
Performs complex microbiological testing per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches. Testing may include, but is not limited to, Bioburden, Endotoxin, Culture Purity, and Microbial Identifications.
Reviews technical data, authors routine and periodic laboratory reports (e.g., EM trend reports) and contributes to technical documentation and assessments.
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.
Leads laboratory deviations and investigations.
Identifies and solves problems while informing and consulting with area management.
Participates in project developments from concept through execution, ensuring alignment with organizational goals.
Partners with laboratory management in scheduling of daily, weekly, and non‑routine testing and tasks.
Provides technical guidance and mentorship to junior analysts.
Participates or leads laboratory equipment qualification or validation.
Troubleshoots assay and method issues with the support of laboratory management.
Troubleshoots laboratory equipment when issues arise.
Performs other duties, as assigned.
Knowledge, Skills or Abilities
Strong working knowledge of aseptic techniques and behaviors.
Effective communication, both written and verbal.
Superior 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.
In‑depth understanding and working knowledge of 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.
Expertise 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.
Minimum Education Requirements
High School Diploma and at least 8 years of laboratory experience in a cGMP environment.
Associate’s degree in Life Science, Pharmaceutical, or related field with at least 6 years of laboratory experience in a cGMP environment.
Bachelor’s degree in Life Science or Biology with at least 4 years of experience in a cGMP environment.
Preferred Experience
BioWork Certificate.
Physical Requirements
Will work in an environment which may necessitate respiratory protection.
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 (240 minutes).
Ability to sit for prolonged periods of time (240 minutes).
Ablity to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
Ability to conduct work that includes moving objects up to 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18 to 60 inches in height, and use twisting motions.
Will work in warm/cold environments (0‑100°F range).
EEO Information 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.
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 (HR_FDBU@fujifilm.com).
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Company Overview At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life‑impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you. From our Bioprocess Innovation Center to our cGMP‑compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare. Situated at the cross‑section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities. Fujifilm is globally headquartered in Tokyo with over 70,000 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: https://www.fujifilm.com/us/en/about/region/careers
Job Description
Performs complex microbiological testing per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches. Testing may include, but is not limited to, Bioburden, Endotoxin, Culture Purity, and Microbial Identifications.
Reviews technical data, authors routine and periodic laboratory reports (e.g., EM trend reports) and contributes to technical documentation and assessments.
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.
Leads laboratory deviations and investigations.
Identifies and solves problems while informing and consulting with area management.
Participates in project developments from concept through execution, ensuring alignment with organizational goals.
Partners with laboratory management in scheduling of daily, weekly, and non‑routine testing and tasks.
Provides technical guidance and mentorship to junior analysts.
Participates or leads laboratory equipment qualification or validation.
Troubleshoots assay and method issues with the support of laboratory management.
Troubleshoots laboratory equipment when issues arise.
Performs other duties, as assigned.
Knowledge, Skills or Abilities
Strong working knowledge of aseptic techniques and behaviors.
Effective communication, both written and verbal.
Superior 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.
In‑depth understanding and working knowledge of 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.
Expertise 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.
Minimum Education Requirements
High School Diploma and at least 8 years of laboratory experience in a cGMP environment.
Associate’s degree in Life Science, Pharmaceutical, or related field with at least 6 years of laboratory experience in a cGMP environment.
Bachelor’s degree in Life Science or Biology with at least 4 years of experience in a cGMP environment.
Preferred Experience
BioWork Certificate.
Physical Requirements
Will work in an environment which may necessitate respiratory protection.
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 (240 minutes).
Ability to sit for prolonged periods of time (240 minutes).
Ablity to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
Ability to conduct work that includes moving objects up to 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18 to 60 inches in height, and use twisting motions.
Will work in warm/cold environments (0‑100°F range).
EEO Information 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.
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 (HR_FDBU@fujifilm.com).
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