Lead QC Associate 2- Second Shift (10am-8 pm Wed-Sunday)

Fujifilm • Durham, NC

289d

About The Position

The QC Microbiology Lead Associate 2 is a position that supports a broad range of microbiological disciplines and manages multiple assignments of increasing complexity and responsibility within the Quality Control laboratory. This is Second shift (Sat- Wed 10am-8pm). The individual performs high throughput, right-first-time laboratory work to meet production schedules and project milestones and will work with little to no supervision. They are expected to follow procedures and have mastery of a variety of microbiological methods and supporting data management processes. The individual effectively and efficiently manages complex or difficult tasks. Microbiological disciplines common to the laboratory include but are not limited to aseptic technique, environmental and clean utility monitoring, bioburden and endotoxin determination, Gram staining, non-host (culture purity) testing, stock culture preparation and maintenance, cell culture maintenance, and associated viral titer assays. The position primarily works independently taking direction from their manager or senior department staff, meanwhile providing direction to junior analysts and peers within the department. Individuals in this role are expected to have expertise within the assigned disciplines and act as subject matter experts. Incumbents in this role will have primary assigned responsibility for Environmental Monitoring functions or Microbiology support, depending upon department needs and individual capacity.

Requirements

• BS/BA in science, preferably in chemistry, biochemistry, pharmaceutical sciences microbiology or biological sciences.
• Advanced technique skills and capability to identify and implement process improvements.
• Familiarity with basic statistical tools to analyze data.
• Familiarity with data management processes such as Trackwise and LIMS.
• Ability to manage multiple tasks effectively.
• Strong communication skills to build trust and respect with colleagues.
• Ability to achieve Yellow Belt Certification within the company's Six Sigma program.
• Technical writing skills for protocols, deviations, and complex reports.
• Problem-solving and troubleshooting competencies.
• Ability to make informed and timely decisions independently.

Nice To Haves

• 6-8 years related laboratory experience (4 years required with relevant MS degree).
• Complete understanding and knowledge of procedures and practices in assigned area.
• Demonstrated subject matter expertise and responsibility for CAPAs, audit actions, deviations, and lab investigations.
• Embrace lean lab and Six Sigma principles.
• Ability to review and interpret technical data and generate reports.

Responsibilities

• Perform high throughput, right-first-time laboratory work to meet production schedules and project milestones.
• Follow procedures and demonstrate mastery of microbiological methods and data management processes.
• Manage complex or difficult tasks effectively and efficiently.
• Work independently while taking direction from management and providing guidance to junior analysts.
• Act as a subject matter expert in assigned microbiological disciplines.
• Have primary responsibility for Environmental Monitoring functions or Microbiology support.
• Support all necessary laboratory and assay functions, including housekeeping, safety, and equipment maintenance.
• Notify management and initiate events in the quality systems.
• Prioritize and organize work to deliver assignments according to established schedules and deadlines.
• Contribute to team goals and foster a sense of teamwork within the unit and across the department.

What This Job Offers

• Job Type: Full-time
• Industry: Machinery Manufacturing
• Education Level: Bachelor's degree