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Job Details

GlaxoSmithKline (GSK)

Quality Processes Specialist (334534)





Rockville, Maryland, United States

Site Name: USA - Maryland - Rockville
Posted Date: Apr 28 2022

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 Processes Specialist role could be an ideal opportunity to explore.

The purpose of the Quality Processes Specialist position is to provide support for activities that ensure the site manages and mitigates risk and maintains compliance. The Quality Processes Specialist 1 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.

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

  • 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.
  • Trained as a site Qualified Internal Auditor and participate in at least 2 monitoring audits a year and working towards the competency to be a Lead Auditor.
  • Manage GMP documents by writing, reviewing, and/or managing document workflows
  • Provide metrics and Key Performance Indicators (KPIs) for management of risks and compliance

Why you?

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; good organization skills, attention to detail, ability to multitask, ability to work in a team environment, PC literate.
  • Strong knowledge in computerized systems such as Document Management, ERP, and/or CARISMA Plateau
  • 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
  • Ability to work in a cross-functional team as a team member
  • Attention to detail and good organizational skills

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.

With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.

Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.


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At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

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