Sr. Analyst, QC Sample Control

Fujifilm - Holly Springs, NC

Full-time

Holly Springs, NC

Machinery Manufacturing

About the position

The Sr. Analyst, QC Sample Control plays a crucial role in managing and documenting samples within the Quality Control (QC) department at FDB's state-of-the-art Life Science Manufacturing Facility. This position involves ensuring compliance with internal procedures for sample handling, coordinating stability samples, and collaborating with internal stakeholders for the transport of QC samples. The role requires a high level of attention to detail and effective communication skills in a fast-paced, technical environment, with responsibilities extending to routine on-call and weekend support as needed.

Responsibilities

• Supports the setup of the Sample Management lab during Project phase including authoring procedures and sample collection.
• Orders lab supplies for the QC department and creates logbooks for QC activities.
• Facilitates the movement of QC samples from Manufacturing to the QC labs while maintaining sample chain of custody and GMP documentation.
• Acts as Subject Matter Expert (SME) overseeing Stability sample sets and pulling samples per protocol.
• Receives, inspects, and inventories reference materials and samples from external sources.
• Documents sample receipt, storage, and movement in Labware LIMS and internal forms.
• Collaborates cross-functionally to address sample issues from manufacturing, laboratories, or the warehouse.
• Assists in authoring and reviewing SOPs, protocols, and reports related to Sample Management and Stability Studies.
• Creates Certificates of Analysis (CoA) and result summary reports for batch disposition.
• Supports continuous improvement projects and SOP revisions.

Requirements

• Bachelor's degree in Science (Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences) with 3+ years of relevant experience, or a Master's degree with 1 year of relevant experience.
• 1-3 years of relevant experience in a GMP environment.
• Availability to work weekends as part of the schedule.

Nice-to-haves

• At least 1 year of experience with Labware LIMS or working with a LIMS in a cGMP Quality Control department.
• Experience using Trackwise system.
• Experience working in a laboratory environment.
• Basic familiarity with statistical tools for data analysis.
• Ability to incorporate lean lab and six sigma principles into daily work.