Scientist 1, QC Microbiology

Fujifilm • Holly Springs, NC

2d

About The Position

The Scientist 1, QC Microbiology supports a broad range of microbiological functions for both raw materials and drug product manufacturing support. This role manages multiple assignments of increasing complexity and responsibility within the Quality Control laboratory in support of these two areas. This role follows procedures and has mastery of a wide variety of microbiological methods specific to raw material and drug product manufacturing and supporting data management processes. The Scientist 1, QC Microbiology effectively and efficiently manages complex or difficult tasks with expertise within the assigned disciplines. This role initially supports the commissioning activities involved in the construction of a new Biopharmaceutical manufacturing facility and laboratory. Flexibility in job roles and assignments are required.

Requirements

• Bachelor’s degree in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 5+ years’ experience OR
• Master’s degree in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 3+ years’ experience OR
• PhD with 1+ years of applicable industry experience
• 3+ years of experience working in a regulated GMP environment
• Expert understanding of GMP, GLP, GDP requirements
• Experience and proficient knowledge in Microbiology theory
• Experience and proficient knowledge of Microbiology testing and laboratory experience, specific to both Drug product manufacturing support and raw materials testing
• Advanced LIMS experience
• Advanced experience with document control including writing and editing technical documents and presentations

Nice To Haves

• SME level knowledge in Microbiology theory
• SME level knowledge of Microbiology testing and laboratory experience, specific to both Drug product manufacturing support and raw materials testing
• Investigations training (Trackwise or similar)
• LEAN/6S certification
• Familiarity with global regulatory guidelines and testing implications

Responsibilities

• Performs non-routine complex testing, identifies requirements and executes actions as part of change control process. Assists and guides others in the lab with routine testing
• Performs high throughput, right-first time work to meet production schedules and project milestones with minimal/no supervision
• Leads qualification and study directed testing activities
• Reviews and evaluates advanced lab testing results
• Acts as a qualified trainer and Subject Matter Expert (SME) of multiple tests
• Authors, reviews, and edits documents and study protocols
• Supports intermediate investigations of OOS assays and events
• Ensures compliance with cGMP and participates in audits and inspections
• Supports laboratory management and mentors’ others on the team, as needed
• Leads LEAN lab and six sigma principles and applies them to laboratory processes
• Acts as project leader for projects in the lab and department
• Leads audit readiness and participates/supports for the team
• Performs other duties, as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees