Senior Quality Assurance Specialist

GlaxoSmithKline Consumer Healthcare, L.P.

Site Name: USA – Montana – Hamilton
Posted Date: Aug 6 2024

The Senior Quality Assurance Specialist will represent operational QA to ensure the safety, quality and efficacy of product by providing direct support to customers in the production value streams (commercial and product-related), Quality Control, Technical Services (e.g. Facilities, Engineering and Calibration) and the Validation teams. Coaching and Mentoring of site personnel in order to promote a consistent Quality Mindset and understanding of both Patient Safety and Regulatory Compliance will be paramount in this role. The incumbent will support manufacturing operations across two shifts to mimic the Manufacturing schedules and to ensure a consistent Quality Mindset for all teams as GSK Hamilton. There will also be opportunity to support Validation and Qualification activities for new systems, equipment, processes and infrastructure related to adjuvant manufacturing as needed and assigned.

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

  • Quality Systems: may be responsible for management of the following major quality systems: Change control, CAPAs, Deviations. Management of systems includes reporting and training as necessary.
  • Quality: supports GMP compliance and inspection readiness within organization.
  • Investigations: may be responsible for performance, review and approval for investigations associated with complaints, deviations, CAPAs, Out of Specification, Out of Tolerance, Atypical results.
  • QA Validation review: Review validation and qualification documents for QA content, Compliance, and Regulatory impact.
  • Environment Health and Safety: responsible for application of safety and environmental guidelines.
  • Quality and Compliance: execute all activities following quality and regulatory standards and procedures. Promote a quality mindset and quality excellence approach to all activities.
  • Continuous Improvement: Champion a culture of continuous improvement, and industrial excellence methodologies.
  • Accountability: support employees and respective departments in a manner which is clear in approach, communication and action. Provide proactive communication to customers to ensure timely escalation and resolution of issues. Follow up on issues to ensure completion in a timely manner. Support cross functional communication in all matters.

Why you?

Basic Qualifications:

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

  • Bachelors Degree in Scientific Discipline and 3 years of experience in a cGMP regulated environment
  • OR, Associates degree in a scientific field with 5 years pf experience in a cGMP regulated environment with Quality Assurance experience
  • OR, High School Diploma or equivalent with 7 years of experience in a cGMP regulated environment with 3 years as part of the Quality Assurance function

Preferred Qualifications:

  • Bachelors Degree with specialization in Computer Validation or QA for Computerized Systems
    5 years experience in cGMP pharmaceutical environment or related industry focused on quality operations
  • Demonstrated experience and working knowledge of cGMPs and associated regulatory requirements and guidelines for the manufacture, testing, and release of pharmaceutical/biopharmaceutical products required.
  • Significant understanding of US and European GMP regulations.
  • Strong verbal and written communication skills.
  • Ability to work successfully both independently and in a team environment.
  • Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QC.
  • Use and understanding of SAP system.
  • Microbiology Background
  • Chemistry Background Automation
  • Automation Engineering Experience

#LI-GSK

#LI-Onsite

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, its 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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  • Date Posted: November 15, 2024
  • Location: Hamilton, MT