Operational QA Coordinator

Are you energized by a quality assurance role that allows you to accelerate compliance in a state of the art manufacturing environment? 

The purpose of the QA Coordinator position is to provide operational quality support to the site for new and existing products, review records to ensure compliance with local and regulatory guidelines, and to execute Quality Systems actions. These actions are executed through direct interaction 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, ensuring compliance with GSK internal procedures, policies, standards, and worldwide regulatory expectations. This role provides quality decisions to project teams and to quality control laboratory teams.

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

• Review laboratory 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.
• Assist in data collection and preparation of trend analysis reports.
• Review for abnormal trends or indications of major problems.
• Ensure adherence to cGMP, CFR, and other governmental 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.
• This role may manage or support closure of Quality system records including lab investigations, deviations, corrective and preventative actions, and master data records.
• Update departmental documents such as SOPs as required.
• Coach lab analysts on quality mindset, good documentation practices, and problem solving skills through GEMBA & time on the floor.

Why you?

Basic Qualifications:

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

• BA/BS
• 1+ years’ experience with cGMP (current Good Manufacturing Practices)
• 1+ years’ experience in quality systems (deviation, validation, documentation, change controls, or auditing/compliance)

Preferred Qualifications:

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

• Good written communication, organizational, and computer skills.
• Good interpersonal and verbal skills required. 
• The incumbent is responsible for adhering to all GSK safety guidelines and procedures
• Able to function within team-based organization.
• Able to prioritize and decide appropriate course of actions. Effective at implementing decisions.
• Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QC

#LI-GSK

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