Quality Processes Specialist

GSK is currently looking for a Quality Processes Specialist to join our team in Rockville, MD. The purpose of the Specialist position is to provide support for activities that ensure the site manages and mitigates risk and maintains compliance. The Quality Processes Specialist uses their skills and knowledge to perform the activities required to ensure senior staff have the data and information to ensure risks, compliance, and assessments can be performed effectively.

Key Responsibilities:

• Track and assess supplier-initiated changes and vendor complaints.
• Manage change control associated with supplier changes.
• Manage data collection forms for supplier-related changes.
• Manage data collection forms for new and changed part numbers.
• Support site Inspection Readiness initiatives including self-inspections, monitoring audits, third- party and regulatory inspections.
• Support Data Integrity reviews at the site.
• Manage GMP documents by writing, reviewing, and/or managing document workflows
• Provide metrics and Key Performance Indicators (KPIs) for management of risks and compliance

Basic Qualifications:

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

• BS Degree with a minimum of 2 years GXP experience
• Experience working in a GMP regulated environment in a role directly related or supporting Quality or Manufacturing

Preferred Qualifications:

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

• Good communication and interpersonal skills; ability to multitask, ability to work in a team environment, PC literate.
• Strong knowledge in computerized systems such as Document Management, ERP, and/or VQMS
• Strong written and communication skills including group presentations and training
• Ability to work in a cross-functional team as a team member
• Attention to detail and good organizational skills
• Strong written and communication skills including group presentations and training

#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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