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.

Responsibilities:

• As a highly skilled specialist, contributes to the development of concepts and techniques. Completes complex tasks in creative and effective ways.
• Acts independently to determine methods and procedures on new assignments. Often acts as a facilitator and team leader.
• Consistently works on complex assignments requiring independent action and a high degree of initiative to resolve issues. Makes recommendations for new procedures.
• 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 batches.
• Reviews technical data, authors routine and periodic laboratory reports (e.g., Environmental Monitoring (EM) trend reports) and contributes to technical documentation and assessments.
• Supports 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) compliance.
• Partners with management for technical services, such as initiating events (e.g., deviations and non-conformances) within quality systems.
• Leads laboratory deviations and investigations.
• Identifies problems, recommends and implements solutions while consulting with management.
• Leads and participates in project developments from concept through execution, ensuring alignment with organizational goals.
• Partners with laboratory management to schedule daily, weekly, and non-routine testing and tasks.
• Provides technical guidance and mentorship to junior associates.
• Participates in laboratory equipment qualification and validation activities.
• Troubleshoots laboratory equipment, assay and method issues with the support of laboratory management.
• Performs other duties, as assigned.

Requirements:

• Associate degree in Life Science, Pharmaceutical, or related field with 6+ years of laboratory experience in a CGMP environment; or
• Bachelor’s degree in Life Science, Pharmaceutical, or related field with 4+ years of experience in a CGMP environment
• Experience with data management systems (e.g., LIMS, TrackWise)
• 6+ years of experience in a CGMP Microbiology laboratory
• Advanced knowledge of aseptic techniques and behaviors
• Effective 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

Physical Requirements:

• Ability to stand for prolonged periods of time up to 60 to 120 minutes.
• Ability to sit for prolonged periods of time up to 60 to 120 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.
• Ability to operate machinery and/or power tools.
• Ability to conduct work that includes moving objects up to 10 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.
• Will work in warm/cold environments (2-8C Range).

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

*#LI-Onsite