Associate Site Investigation Specialist

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.

As a Site Investigation Specialist, you would be responsible for identifying and analyzing non-conformances to determine their root causes and develop corrective and preventive actions (CAPA) in alignment with GSK Global Standards. This role is critical in ensuring product quality, patient safety, regulatory compliance, and maintaining the facility's License to Operate. The specialist acts as a key contributor in upholding the integrity of manufacturing processes and the reliability of product outcomes.

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

• Serve as the Lead Investigator for deviations by utilizing the standardized processes learned and completed through the GSK Orange Belt Training and Certification program
• Utilize DMAIC problem-solving and GSK Production System (GPS) tools to improve efficiency, eliminate waste, and prevent non-compliance events.
• Conduct thorough and timely investigations of deviations, non-conformances, and other quality events, ensuring all relevant information is collected and analyzed.
• Utilize appropriate problem-solving tools and techniques to identify root causes and implement effective corrective and preventive actions (CAPAs).
• Collaborate with cross-functional teams such as production, quality assurance, quality control, engineering, labs, and warehouse to gather information and support the implementation of CAPAs.
• Prepare comprehensive investigation reports documenting findings, root causes, and CAPAs with accuracy and compliance to regulatory and internal standards.
• Serve as an expert in the Validated Quality Management System (VQMS) for tracking, managing, and documenting investigations, while providing training and support for effective system utilization.
• Deliver training and guidance to personnel on investigation processes, root cause analysis techniques, and deviation management to foster a quality-focused culture.
• Adhere to ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate) for all documentation tasks.
• Own deviation and environmental monitoring investigations, write-ups, corrective and preventive action management, impact assessments, and simple change controls.

Why you?

Basic Qualifications:

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

• Bachelors degree

• 1+ years of GMP processing and/or industry related experience, exhibiting a skillset of supporting all aspects of production processing and demonstrating technical competency.

Preferred Qualifications:

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

• Bachelor's of Science
• Familiar with cGMP's, regulatory guidelines, governmental codes, and standard operating procedure.
• Orange Belt Certification

#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 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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