Are you looking for an opportunity to support a Quality Management team in the day to day operations in a manufacturing environment?  If so, this is the role for you.

As QA Systems Documentation Coordinator you will be responsible for understanding and maintaining cGMP documents under the responsibility of the Quality systems group including, but not limited to, standard operating procedures, equipment logbooks, and archived documents.  This position will provide consistent compliant approach to GMP documentation. 

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

• Responsible for daily oversight activities for cGMP procedures management/Master Batch Records/Quality Management Checklists/eSOP which includes the processing all LSOPs/Appendices and MBRs as Document Administrator.
• Responsible for the daily oversight for cGMP documentation archival process which includes management of the database and documentation control and chain of custody within the management of that system. This responsibility involves lifting (documentation boxes). 
• Responsible for the daily oversight of the logbook documentation process.
• Complete all work with highest regard to quality and compliance with GMPs.
• Responsible for execution of training activities on cGMP quality systems (Qualified Trainer).
• Participate in quality systems improvement/simplification project and site initiatives as applicable.
• Participate in quality systems monitoring and metrics reporting
• Responsible for daily activities regarding Quality Systems documents related to Easy Doc.
• Responsible for compliance with the GSK safety procedures and all 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:

• HS Diploma or equivalent
• 2 years' prior work experience maintaining and controlling records and documentation
• 2 years' prior work experience in documentation control role primarily within a GMP facility.
• 2 years' prior work experience in electronic document lifecycle systems

Preferred Qualifications:

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

• Prior work experience working in Microsoft
• Strong communication skills
• Ability to follow written procedures and document results in a neat and precise manner
• Demonstrated ability to work well with others
• Experience working in SAP based systems
• Computer skills to include:  computer software applications, Word, Excel.
• Working knowledge of validation principles, quality systems and FDA regulations.
• The ability to maintain attention to detail and quality and a high level of integrity and confidentiality, while completing multiple or repetitive tasks and meeting timelines and deadlines.

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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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