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 own Laboratory Support systems and processes for QC, including: LES (Laboratory Execution System), Labware, SWB (Supportive Workbook) creation, experiment creation, builds, implementation, and hypercare/update. This position also executes non-routine, non-testing tasks within QC, including electronic change management, and LES training. 

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 Laboratory Execution System, implementation, updates, and execution of tasks.
• Local Business Owner for QC LES Module.
• Maintain LES processes and perform training to grant QC LES roles to users/administrators.
• Generate/Update LES master data related to QC (experiments, supportive workbooks, reagent and equipment management, etc.). 
• Ensure that all data is complete and accurate.
• Serve as LES Module SME for method implementation and improvement.
• Support business during method creation and revisions within LES – 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 all laboratories to optimize all LES associated masterdata

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.  Degree in other discipline with 2 years' experience in LIMs system
• Minimum of 3 years' experience in cGMP-regulated environment.
• Minimum of 2 years' experience with LIMs, SAP, and/or LES is required.

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.

Why GSK?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 Get Ahead Together.

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Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why Us?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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