QA Specialist

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 Specialist 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 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 regulatory audits. May support or conduct internal audits and prepare summary reports.
• 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.
• 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 and review departmental documents such as SOPs as required

Why you?

Basic Qualifications:

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

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

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.
• 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.

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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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