Quality Assurance Specialist

3 weeks ago

Durham, North Carolina, United States GlaxoSmithKline Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at GlaxoSmithKline. As a Quality Assurance Specialist, you will be responsible for providing quality oversight to support the implementation and maintenance of strategic computerized systems. You will ensure that these systems are validated and operated in accordance with company and regulatory requirements.

Key Responsibilities
  • Fulfill the Quality Assurance responsibilities in the preparation and approval of Computer System validation records or manage the process in accordance with relevant procedures.
  • Provide input to the validation planning of high-cost, complex, strategic systems using risk-based approaches to ensure systems are fit for purpose.
  • Provide and/or facilitate quality assurance oversight for the automation of business processes related to pharmaceutical manufacture, laboratory, and distribution.
  • Identify, resolve, and avoid project problems, typically involving ongoing interaction with management teams within Tech functions, Site, and Local Operating Company Quality organizations, and Third-Party suppliers/service providers.
  • Participate in the deployment, maintenance, and inspection support of multiple global projects with responsibility for developing solutions that maintain compliance and keep validation on schedule and within budget.
  • Ensure that issues and risks are identified, mitigated, and/or escalated for matters that could adversely impact quality compliance associated with projects and systems, while providing performance measures to drive performance and continuous improvement.

Requirements
  • Bachelor's degree or equivalent industry experience/subject matter expertise.
  • Understanding of pharmaceutical manufacturing and distribution regulations, guidelines, principles, and expectations.
  • Broad experience in independently providing validation, deployment, change management, and inspection support of large, complex, computerized systems.
  • Demonstrated ability to interpret and apply company guidelines, principles, and expectations such that systems are validated in proportion to the risk they present to patient safety and product quality.
  • Experience as an effective communicator with ability to collaborate and form strong partnerships within teams and diverse stakeholders/customers that result in 'win-win' outcomes to achieve business goals and objectives.

Preferred Qualifications
  • B.S. or advanced degree in Computer Science, Engineering, Pharmacology, or related sciences.
  • Technical knowledge to support quality and validation decision making for GxP analytical, manufacturing, distribution, and IT computerized systems.
  • Demonstrated ability to handle multiple priorities and complete work within agreed timescales e.g. key QA role deliverables.
  • Demonstrated ability to successfully manage support to regulatory inspections including specific queries of computer systems validation/compliance activities and documentation.

About Us
GlaxoSmithKline is a global biopharma company with a special purpose - to unite science, technology, and talent to get ahead of disease together. 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).

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