Reference #: 405899
Site Name: USA - Pennsylvania - Marietta
Posted Date: Oct 8 2024Are 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 Lead Administrator role could be an exciting opportunity to explore.The LES Lead Administrator owns the Laboratory Support systems and processes for QC, including: Labware/LES (Laboratory Execution System), SWB(Supportive Workbook) creation, LES experiment creation/method builds, and implementation, LES equipment/reagent management and implementation, and system hypercare/updates. This position also executes non-routine, non-testing tasks within QC, including electronic change management, advanced troubleshooting, 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 master data
Drive change and improvements to the Labware environment based on user feedback and requests; prioritize and coordinate implementations in an efficient and right-first-time manner.
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 5 years' experience in cGMP-regulated environment using LabWare
Minimum of 3 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 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
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 su tainable 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.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
