LES Administrator

GlaxoSmithKline - Marietta, GA

Full-time - Mid Level

Marietta, GA

Chemical Manufacturing

About the position

The LES Administrator role at GSK involves managing Laboratory Support systems and processes for Quality Control (QC), focusing on Master Data, Monograph Creation, Stability, and Laboratory Execution Systems (LES). This position is responsible for executing non-routine tasks within QC, including electronic change management and SAP training, while serving as the Local Business Owner for LES/SAP QC Master Data. The role emphasizes a strong safety culture and compliance with established EHS policies, while collaborating with various teams to optimize processes and ensure compliance.

Responsibilities

• Drive a strong safety culture within QC and the site.
• Adhere to established EHS policies and procedures.
• Own QC, LES, Master Data, and execution of tasks.
• Act as Local Business Owner for QC LES and SAP Modules.
• Maintain LES/SAP processes and perform training to grant QC SAP roles to users.
• Generate master data related to QC (monographs, specifications, inspection plans, etc.).
• Ensure that master data is complete and accurate.
• Serve as SAP Module/LES Subject Matter Expert (SME) for method implementation and improvement.
• Support business during method creation and revisions within LES and SAP.
• Collaborate with QC teams, global team, support teams, and other sites to ensure compliant processes.
• Benchmark with GSK sites to ensure processes are optimized and in alignment within the network.
• Work closely with biochemistry and microbiology laboratories to optimize all LES methods.

Requirements

• B.S or B.A in Microbiology, Biochemistry, or a related scientific discipline.
• Minimum of 3 years' experience in a cGMP-regulated environment.
• 1 year of previous administrator experience with LIMs, SAP, and/or LES is preferred.

Nice-to-haves

• Experience with LabWare.
• Working knowledge of pharmaceutical facilities, equipment, and systems.
• Knowledge of GMP's, NIH Guidelines, FDA, and other regulatory agency requirements sufficient to apply to quality operations and compliance.
• Ability to communicate both verbally and in writing with all levels inside and outside of the organization.
• Ability to clearly write technical documentation as necessitated by regulatory agencies and internal policy.
• Ability to establish and maintain working relationships with staff and analyze data to implement changes.
• Aptitude for facilitating a team environment and working independently toward the goal of completing product investigations.
• Strong technical writing skills.

Benefits

• Comprehensive benefits program including health insurance, retirement plans, and paid time off.