QA Coordinator

We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021.

We continue to modernize, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together.

The purpose of this position is to provide support to the site when implementing new products, review of records to ensure compliance with local and regulatory guidelines, and to execute Quality Systems actions. This is done through direct intervention between this role and other staff in the facility. This role may develop, implement and administer input and in-process electronic quality systems for the production of biopharmaceutical products ensure compliance with GSK internal procedures, policies, standards, and worldwide regulatory expectations. This role will act as advisor, facilitator and team member regarding regulatory compliance and quality systems for all aspects of manufacturing of biopharmaceutical products. This is done through direct intervention between this role and other staff in the facility. This role provides quality decisions to project teams and to routine operating teams. This position will provide guidance and training to new and existing employees in the Quality Assurance department and assist them with decision making.

This candidate has to be comfortable with being on site and have open availability to working the Day shift (5AM - 5PM) and night shift (5PM-5AM) depending on team needs.

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

• Collect and evaluate information to assist in internal and vendor audits. May support or conduct internal audits and prepare summary reports. Manage vendor lists.

• Review production and control records using established procedures and guidelines to support lot release of raw materials, components and finished goods.

• Administer electronic systems using established procedures and guidelines to support lot release of raw materials, components and finished goods.

• Support special projects, such as validation, site priority, or new products as required.

• Supports and/or assures completion of annual product reviews. Assist in data collection and preparation of trend analysis reports. Review for abnormal trends or indications of major problems.

• Advanced knowledge in cGMP, CFR and other regulations in order to assure quality compliance.

• Performs review of documents related to change management such as work order review.

• Perform review of technical documents such as for equipment and process validation, automation and computer validation.

• Manages or supports closure of Quality system records including investigations, corrective and preventative actions, and change control.

• Update departmental documents such as SOPs as required.

Basic Qualifications:

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

• BS or BA in relevant technical discipline (Biology, Chemistry, Engineering, Biochemistry, Computer Science, Computer Engineering, or related fields). Or 2 years of experience in biopharma industry will be considered in lieu of technical degree.
• 2 years of experience in quality systems, including validation, documentation, compliance department.
• 2 years working in a GMP regulated environment, NIH Guidelines, FDA and other regulatory agency requirements.

• Needs to have an open availability as could potentially be working either day shift or night shift depending on team needs

Preferred Qualifications:

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

• Ability to adhere to all GSK safety guidelines and procedures.

• Good written communication, organizational, and computer skills.

• Good interpersonal and verbal skills.

• Ability to function within team based organization.

• Ability to prioritize and decide appropriate course of actions.

• Ability to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QC.

Please visit 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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