Are you looking for a quality compliance role where you can enhance your project management expertise in a state of the art manufacturing environment?  If so, this QA Systems Specialist role could be an exciting opportunity to explore.

As a QA Systems Specialist, you will be responsible for the oversight, monitoring, and reporting function to support quality systems that are used at Marietta facility to support production of vaccines

This role will provide YOU the opportunity to lead key activities to progress YOUR career.  These responsibilities include some of the following:

• Responsible for quality system process expertise and daily oversight activities for cGMP quality systems.
• Responsible for ensuring the Quality Systems LSOP/processes are robust and compliant with Regulatory and global requirements.
• Responsible for reporting and monitoring on cGMP quality systems, site KPIs, and other miscellaneous quality unit systems.
• Responsible for execution of training activities on cGMP quality Systems (Qualified Trainer)
• Responsible for acting as QA liaison with QA operations to site personal to resolve technical problems or provide quality system expertise to help provide solutions while still assuring compliance to cGMP.
• Responsible for acting as QA liaison with global support functions to resolve technical problems or provide quality system expertise to help provide solutions while still assuring compliance to cGMP
• Responsible for backup roles for Quality Systems Manager when applicable.
• Responsible for backup roles for documentation systems responsibilities within the quality systems disciplines (includes; procedures management, documentation control, archival & logbooks).  This also supports any Records Champion responsibilities (i.e. lighten up)
• Lead quality systems improvement/simplification project and site initiatives as applicable.
• Complete all work with highest regard to quality and safety by ensuring compliance with GMPs, applicable EHS regulations, standard operating procedures, and industry practices

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree in sciences or business
• 3+ years pharmaceutical experience in a Quality Organization

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Versed in GMP’s, NIH Guidelines, FDA and other regulatory agency requirements for validation and operations, analytical and stability functions and compliance
• Experience with implementation in deviation management, CAPA, or change control, and verses in reporting and KPI functions
• Strong communication and problem solving skills with a demonstrated ability to work well with and influence others without direct reporting relationships
• Demonstrated ability to work well with and influence others without direct reporting relationships
• Problem solving skills
• Experience in managing process changes.
• Strong technical understanding of industry and science practices related to the business
• SAP Experience
• Experience in startup facility
• Experience with operational excellence concepts
• Experience in process design

#LI-GSK

#mariettavaccines

#globalsupplychain

#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 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 themselve