Job Abstract

Are you energized by a quality assurance role that allows you to accelerate compliance in a state of the art manufacturing environment?  If so, this Quality Assurance Operations Specialist role could be an ideal opportunity to explore.

The hours for this shift are Friday through Monday with flexibility around hours.

As a Quality Assurance Operations Specialist, you will be responsible for providing a link between operations and the various quality systems.  Primary responsibility is to directly support Operations through real-time, on-line batch record QA review and approval. 

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

• Perform technical review of cGMP documentation for completeness and compliance to cGMPs as outlined by governmental regulations and internal procedures.
• Provide advice and counsel on cGMP and related quality assurance issues to the value stream
• Demonstrate sound decision making relating to quality issues
• Provide on the floor QA support and perform QA Operations activities (batch record review and issuance, room release, line clearance, documentation review etc)
• Take initiative to resolve quality documentation concerns (e.g., investigations, deviations, change controls, and other required documentation).
• Perform review and support regarding discrepancies and/or anomalies noted during QA review of associated processes. This includes deviation investigations, customer complaint investigations, et al.
• Alert management of production trends which may serve as forewarning of process or equipment problems. As necessary, initiate CAPA investigations to address these issues.
• Write and/or revise controlled documents in support of job responsibilities.
• Routinely communicate and report deviations from procedures/processes to Quality Assurance Management and initiate appropriate action as necessary.
• Ensure all GMPs, validation, quality, safety and environmental regulations are met. Adhere to all GSK safety guidelines and procedures.

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

• BS/BA in biology, chemical engineering, life sciences. 
• Minimum of 3 years pharmaceutical experience in Quality Assurance preferably in Biologics Secondary Manufacturing or 3 years as a manufacturing technician in a Biologics Secondary Manufacturing operation.

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.
• Training and work experience in root cause analysis tools (Isikawa) and statistical analysis (TQM, SAS) required.
• Knowledge of GMP’s, NIH Guidelines, FDA and other regulatory agency requirements sufficent to apply to quality operations and compliance.  Working knowledge of validation principles, aseptic processing, quality systems and FDA regulations.
• The ability to communicate both verbally and in writing with all levels both inside and outside of the organization.  The ability to clearly write QA documentation as necessitated by regulatory agencies and internal policies.
• Able to prioritize and decide appropriate course of actions and to effectively implement decisions.
• Ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions and implement decisions.
• Project Management experience a plus
• Packaging Operations experience a plus

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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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