The Lead Associate 2, Quality Control (QC) Microbiology oversees and guides the critical operational functions of the QC Microbiology laboratory. This position holds the responsibility for conducting microbiological assays, as well as effectively trains junior analysts in these areas. The role is pivotal in guaranteeing “right the first time” execution to support timely batch disposition of manufacturing goods. Additionally, this role ensures technical issues are promptly escalated to laboratory management and upholds high standards of accuracy and efficiency within the laboratory operations.
Company OverviewAt 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
What You’ll Do
Performs complex microbiological testing (e.g., Bioburden, Endotoxin, Culture Purity, and Microbial Identifications) per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batchesReviews technical data, authors routine and periodic laboratory reports (e.g., Environmental Monitoring (EM) trend reports) and contributes to technical documentation and assessmentsSupports client audits and regulatory inspections as an assay or method Subject Matter Expert (SME)Ensures laboratory maintains inspection readiness, data integrity, and Current Good Manufacturing Practice (CGMP) compliancePartners with management for technical services, such as initiating events (e.g., deviations and non-conformances) within quality systemsLeads laboratory deviations and investigationsIdentifies problems, recommends and implements solutions while consulting with managementLeads and participates in project developments from concept through execution, ensuring alignment with organizational goalsPartners with laboratory management to schedule daily, weekly, and non-routine testing and tasksProvides technical guidance and mentorship to junior associatesParticipates in laboratory equipment qualification and validation activitiesTroubleshoots laboratory equipment, assay and method issues with the support of laboratory managementPerforms other duties, as assignedKnowledge and Skills
Advanced knowledge of aseptic techniques and behaviorsEffective communication, both written and verbal
Advanced technical writing and problem-solving skills
Ability to complete work independently and 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 knowledge of United States Pharmacopeia and European Pharmacopeia
Ability to support audit readiness for the laboratory
Ability to 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
Basic Requirement
Associate degree in Life Science, Pharmaceutical, or related field with 6+ years of laboratory experience in a CGMP environment; orBachelor’s degree in Life Science, Pharmaceutical, or related field with 4+ years of experience in a CGMP environmentExperience with data management systems (e.g., LIMS, TrackWise)Preferred Requirement
6+ years of experience in a CGMP Microbiology laboratoryWORKING CONDITIONS & PHYSICAL REQUIREMENTS
Will work in environment which may necessitate respiratory protection. X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. X No Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No YesAbility to ascend or descend ladders, scaffolding, ramps, etc. X No Yes
Ability to stand for prolonged periods of time. No X Yes 60-120 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to sit for prolonged periods of time. No X Yes 60-120 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. No X Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. No X Yes ENVIRONMENTAL
Will work in warm/cold environments. No X Yes 2-8C Range (If yes, specify approximate temperature ranges.)
Will work in outdoor elements such as precipitation and wind. X No Yes
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 InformationIf 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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