Quality Systems Specialist

GSK•Lincoln, NE

13d•Onsite

About The Position

Welcome to Haleon. We’re a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we’ve 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 it’s 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.

Requirements

A minimum of a Bachelor’s 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.

Nice To Haves

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.

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

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.

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