Senior Analyst 1, QC Testing

Fujifilm•Holly Springs, NC

2d•Onsite

About The Position

The Sr. Analyst 1, Quality Control (QC) All QC Team is responsible for performing routine testing required for Urgent/STAT testing of manufacturing batch samples, clean utility, and environmental monitoring. This role is part of a 24x7 team that supports testing/sampling across all of the QC laboratories required for urgent testing/Manufacturing support. The role will learn and perform testing/sampling across multiple labs in QC.

Requirements

Bachelor's with 2+ years of relevant QC 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 of QC testing and laboratory experience
LIMS experience
Experience with document control including reviewing and editing technical documents

Nice To Haves

4+ years of previous experience working within QC or with GXP or quality systems is an advantage
Advanced experience in a GMP QC Laboratory, advanced knowledge of all compendial test methods.

Responsibilities

Performs basic testing that spans all of the QC labs (e.g., Bioburden, Endotoxin, HPLC, UV280, TOC, etc.) per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches
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
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