Senior Analyst 1, QC Microbiology

Fujifilm • Holly Springs, NC

1d • Onsite

About The Position

The Senior Analyst 1, QC Microbiology is responsible for leading key operational aspects of the QC Microbiology laboratory. The Senior Analyst 1, QC Microbiology performs and trains other team members on the microbial testing of all in-process drug substance, drug product, EM/UM, and raw materials samples. This role is responsible for all activities associated with testing in accordance with written procedures. This role primarily works independently with minimal supervision as needed, consults with management on key decisions.

Requirements

• Bachelor's with 2+ years of relevant Microbiology experience; OR, Master's with 0 years of experience.
• Experience with aseptic production & support.
• 1-3 years in a GMP environment.
• Advanced understanding of GMP, GLP, GDP requirements.
• Advanced knowledge in Microbiology theory.
• Advanced knowledge of Microbiology testing and laboratory experience.
• LIMS experience.
• Experience with document control including reviewing and editing technical documents.
• LEAN lab and six sigma six training and/or certification
• Intermediate familiarity with fundamental statistical tools to analyze data in relation to trends results
• Intermediate LIMS software training.
• Knowledge or training of FDA regulations (cGMP, cGLP, cGDP).
• Ability to ascend or descend ladders, scaffolding, ramps, etc…
• Ability to stand for prolonged periods of time for up to 60 minutes.
• Ability to sit for prolonged periods of time for up to 60 minutes.
• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
• 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 small and/or enclosed spaces.
• Will work in heights greater than 4 feet.

Nice To Haves

• Master's with 1+ years of experience.
• 4+ years of previous experience working within QC Microbiology or with GXP or quality systems is an advantage.
• Advanced experience in a GMP QC Microbiology Laboratory, advanced knowledge of all compendial test methods (Bioburden, Endotoxin, Sterility testing).
• Advanced experience with microbial ID systems, ability to trouble-shoot complex equipment and instrumentation (MALDI, MicroSeq).
• Advanced LIMS / Trackwise software training.
• Experience working within a QC laboratory environment commissioning Pharmaceutical and/or laboratory facilities

Responsibilities

• Executes advanced lab testing and support for all laboratory assays for all samples, and acts as a Subject Matter Expert (SME) and qualified trainer of at least one test.
• Leads sample collection and manages sample logistics for testing.
• Supports testing for all qualification and study directed testing.
• Supports investigation of routine OOS assays and events.
• Conducts qualification and validation protocols.
• Leads sterility testing.
• Reviews intermediate lab testing results.
• Troubleshoots complex assays.
• Writes and assists with document preparation and review.
• Manages project timelines.
• Assists management with training and on-boarding of new staff as needed.
• Embraces LEAN lab and six sigma principles and applies them to laboratory processes.
• Champions projects and project management as assigned.
• Performs other duties, as assigned.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior