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Job Details


GlaxoSmithKline (GSK)

Quality Compliance Engineer (501887-gsknch)

Pharmaceuticals

All

Yearly

No

East Durham, New York, United States

Site Name: USA - New York - Oak Hill
Posted Date: May 11 2022

Are you looking for an engineering role that allows you to leverage your technical knowledge in a state-of-the-art manufacturing environment? If so, this Quality Compliance Engineer role could be an ideal opportunity to explore.

As Quality Compliance Engineer, you will manage Quality related programs for Engineering such as Quality CAPAs, Change Controls, Engineering Drawings, GES program management, engineering KPIS and support for other compliance related areas in Engineering

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

  • Support deviation management for Engineering group
  • Establish key performance indicators (KPI's) for engineering area and ensure that are updated and drive continuous industry improvement.
  • Facilitate monthly Engineering Council meetings involving all impacted areas within Engineering.
  • Management of Corrective and Preventive Actions (CAPA), and investigation processes in the Engineering sector, when applicable.
  • Management of the Engineering Area Training Program
  • Management of Engineering Drawings
  • Lead the site change control program for Engineering
  • Management of Engineering document retention and shared file access
  • Assist in other areas of Engineering as needed (i.e. compliance related projects and programs)
  • Support Compliance to Site Quality objectives for Engineering Department
  • Lead and participate in all audits for engineering (LI, L2 and L3 ie: Code inspection audits, L2 site audits, CAG/AA audits, TP13, regulatory audits etc.)
  • Ensure site Maintenance and Calibration programs are aligned and in compliance with QMS and Engineering policies
  • Be the focal point for Engineering Alerts management and be part of Quality Alerts and EHS Alerts investigations
  • Managing the GES gap assessments. Managing and closing out risks identified through Engineering Alerts and GES gap assessments.
  • Assist/manage Change Control, RCA, and CAPA assessment, development, execution and closure.
  • Updating and managing all actions/risk associated with Engineering Metrics KPIs
  • Support Engineering Capital Projects to meet company and site standards upon execution

Why you?

Basic Qualifications:

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

  • Bachelor’s degree in engineering
  • 3+ years experience in a production environment

Preferred Qualifications:

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

  • Bachelor's degree in Chemical or Mechanical Engineering
  • 2+ years of GMP experience
  • Skilled in multi-tasking and prioritizing actions within varying timelines
  • Flexibility to work extended hours as needed to achieve results

Why Consumer Healthcare?

Right now, we’re on an incredible journey as we prepare to become the first independent, 100% focused consumer healthcare company. We’re doing this at a time when the work we do has never mattered more. Better everyday health is about improving the health and wellness of the consumers that we touch every year – over a billion and a half of them – and it goes beyond products. It’s about truly helping people manage their health proactively in different ways as consumer needs evolve.

With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we’re uniquely placed to do this and to grow a strong, successful business.

This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special.

Diversity, Equity and Inclusion

In Consumer Healthcare we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone.

We’re striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your

authentic self belongs and thrives.

*LI-GSK

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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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Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting [Register to View] site.