QA System Coordinator (Biopharma)

The purpose of this role is to develop, implement and administer input into in-process quality systems and/or electronic quality systems for the production of biopharmaceutical products to ensure compliance with GSK internal procedures, policies, standards, and worldwide regulatory expectations. This is done through direct intervention between this role and other staff in the facility. This role provides quality support to project teams and to routine operating teams. This position will provide guidance and training to new and existing employees in the Quality Compliance department. This role ensures adherence to frequency of oversight mandate in the Quality oversight schedule. In addition, this role would support periodic product reviews, internal quality agreements, and post inspection communication assessment and regulatory compliance.

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

• Perform and /or manage adherence to frequency of oversight mandate in Quality oversight schedule.
• Manage and/or support the following Quality Compliance systems (periodic product review, internal quality agreements, post inspection communications, market specific requests, deviation regulatory assessment and change control).
• Support batch connecting process for change controls and release with Operational Quality.
• Support special projects, such as quality improvement initiatives.
• Lead and Support internal audits (Level 1/Level 2) and prepare summary reports. Collect and evaluate information to assist in internal and vendor audits. Support L3/L4 inspections in various functions ranging from control room support, scribe, SME.
• Lead and support completion of annual product reviews and reports for products across the site.
• Support closure of Quality Compliance records including corrective and preventative actions, change controls.
• Update departmental documents such as SOPs as required. Perform the review of technical documents as required.
• Attend meetings as a Quality representative and provide input, including providing updates at Quality Council.
• Support implementation of global strategies as required by the GSK business and QMS.

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

• BS or BA in Quality, Laboratory, or Manufacturing.
• 1+ year's industrial experience in quality, operations, or assurance functions.
• Or 5+ years of work experience can be considered in Lieu of education

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

• Experience in biologics manufacturing, quality systems, including documentation, regulatory compliance, vendor management, and internal auditing

• Knowledge of GMP's, NIH Guidelines, FDA and other regulatory agency requirements preferred.
• 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, production and QC.

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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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