Site Name: USA - Pennsylvania - Marietta Posted Date: Sep 9 2024 Are you looking for a quality compliance role where you can enhance your technical expertise in a state-of-the-art manufacturing environment? If so, this LES Administrator role could be an exciting opportunity to explore. As LES Administrator, you will manage Laboratory Support systems and processes for QC, including: Master Data, Monograph Creation, Stability and LES. This position will execute non-routine, non-testing tasks within QC, including electronic change management, and SAP training. This role will also be the Local Business Owner for LES/SAP QC Master Data. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Drive a strong safety culture within QC and the site. Adhere to established EHS policies and procedures. Owns QC, LES, Master Data, and execution of tasks. 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 SME for method implementation and improvement. Support business during method creation and revisions within LES and SAP – e.g. Data Collection, Prototype, DCMA, BCO and Hypercare 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. Perform all tasks with a safety mindset. Following the EHS guidelines established on site. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: B.S or B.A in Microbiology, Biochemistry, or a related scientific discipline. Minimum of 3 years' experience in cGMP-regulated environment. 1 year Previous administrator experience with LIMs, SAP, and/or LES is preferred Preferred Qualifications: If you have the following characteristics, it would be a plus: Working knowledge of pharmaceutical facilities, equipment and systems. Including a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities. Knowledge of GMP’s, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations and compliance. The ability to communicate both verbally and in writing with all levels both inside and outside of the organization. The ability to clearly write technical documentation as necessitated by regulatory agencies and internal policy. Ability to establish and maintain working relationships with staff and the ability to analyze data and implement changes. Must be able to address complex problems associated with assessing deviations, determination of root cause, and implementation of change and improvement to validated and/or FDA approved production systems. Must have an aptitude for facilitating a team environment and working independently toward the goal of completing product investigations. Participate in cross-functional deviations as needed. Must have strong technical writing skills. #LI-GSK #GSKMarietta #MariettaGSC Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. 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