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Quality Systems Specialist
Quality Systems SpecialistGSK • Lincoln, Nebraska, USA
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Quality Systems Specialist

Quality Systems Specialist

GSK • Lincoln, Nebraska, USA
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  • [job_card.full_time]
[job_card.job_description]

Welcome to Haleon. Were a purpose-driven world-class consumer company putting everyday health in the hands of just three years since our launch weve grown evolved and are now entering an exciting new chapter one filled with bold ambitions and enormous opportunity.

Our trusted portfolio of brands including Sensodyne Panadol Advil Voltaren Theraflu Otrivin and Centrum lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science.

Now its time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose to deliver better everyday health with humanity at the heart of everything we do. It unites us inspires us and challenges us to be better every day driven by our agile performance-focused culture.

About the role

The Quality Systems Specialist supports strategic initiatives aimed at enhancing quality product performance and regulatory compliance across laboratory production and facility operations.

Role Responsibilities

  • Assist in the validation and qualification lifecycle by reviewing and approving change controls protocols discrepancies non-conformances and final reports.
  • Provide quality support to the Validation and Qualification team for both routine tasks and project-based work.
  • Conduct data analysis to support investigations and process improvement initiatives including root cause analysis.
  • Review and support closure of engineering (PM) deviations.
  • Participate in audit and inspection readiness activities.
  • Maintain up-to-date knowledge of cGMPs product types and required training for assigned responsibilities.
  • Perform additional duties as assigned to support departmental and site goals.

Environmental Health & Safety (EHS) Responsibilities All Associates

  • Understand and comply with all EHS guidelines and procedures.
  • Promptly report unsafe conditions injuries illnesses and hazardous material releases.
  • Use appropriate personal protective equipment (PPE).
  • Attend required EHS training sessions.
  • Follow all safe work practices.
  • Quality Responsibilities All Associates

  • Adhere to all quality compliance standards including data integrity QA and QC requirements.
  • Comply with Quality Management System (QMS) policies and applicable regulatory standards.
  • Why you

    Basic Qualifications :

  • A minimum of a Bachelors Degree in Engineering or Science fields (or related field) is required.
  • A minimum of 2 years of hands-on experience in Validation and Qualification within a GMP-regulated environment (preferably in pharmaceutical biotech or medical device industries) is required.
  • Strong background in authoring reviewing and approving validation and qualification protocols and reports for facility systems laboratory instruments equipment and manufacturing processes.
  • Preferred Qualifications :

  • Solid understanding of cGMPs FDA regulatory expectations and industry best practices related to validation and qualification.
  • Proficient in applying risk-based approaches and problem-solving tools (e.g. FMEA 5 Whys) to support validation activities and drive process improvements.
  • Experience conducting data analysis and root cause investigations to support deviations CAPAs and continuous improvement initiatives.
  • Experience in a regulated industry preferred.
  • Location : Lincoln NE with in-office requirements. This is not a remote position.

    Benefits

    Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program. This includes a generous 401(k) plan tuition reimbursement and time off programs including 6 months paid parental leave. On day one you are eligible for benefits including our healthcare programs where the company pays for the majority of your medical coverage for you and your family. We also offer the opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive / recognition programs as part of the offering.

    Job Posting End Date

    Equal Opportunities

    Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture where different backgrounds and views are valued and respected all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. Its important to us that Haleon is a place where all our employees feel they truly belong.

    During the application process we may ask you to share some personal information which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development refinement and execution of our inclusion and belonging programmes that are open to all Haleon employees.

    The personal information you provide will be kept confidential used only for legitimate business purposes and will never be used in making any employment decisions including hiring decisions.

    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 Haleon may be required to capture and report expenses Haleon 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 Haleons compliance to all federal and state US Transparency requirements.

    Accommodation Requests

    If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process please contact us by sending an email to Please include the following in your email :

    Use subject line : Haleon Careers : Job Accommodation Request

    Your Name and contact information

    Requisition ID and Job Title you are interested in

    Location of Requisition (city / state or province / country)

    Description of specific accommodation you are requesting

    Please note : Resumes CVs or other requests outside of accommodation support submitted to this email box will not be accepted.

    Note to candidates

    The Haleon recruitment team will contact you using a Haleon email account (@). If you are not sure whether the email you received is from Haleon please get in touch.

    Required Experience :

    IC

    Key Skills

    Quality Assurance,FDA Regulations,Data Collection,Food Safety Experience,ISO 9001,Mobile Devices,Root cause Analysis,Quality Systems,OSHA,Food Processing,Quality Management,cGMP

    Employment Type : Full-Time

    Experience : years

    Vacancy : 1

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