Overview
Quality Systems Specialist (Belle Mead, NJ, US, 08844)
We are Reckitt
Research & Development
In Research and Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals – all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.
We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.
The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.
This role is not currently sponsoring visas or considering international movement at this time.
About the role
We're in search of a proactive Quality SYstems SPecialist to join the Reckitt team, where innovation and science converge to make a real-world impact. You'll contribute to the growth of our trusted product portfolio, ensuring the highest standards of quality. Your expertise will drive activities from concept to execution, fostering an environment of continuous improvement. If you thrive in a dynamic atmosphere and are looking for a role where your actions directly contribute to the company's success, we would love to see your application.
In this role, you will maintain the site Quality Management System (QMS), completing and coordinating actions across all departments. As well as, assist SMEs in maintaining the Document Management System (DMS), training records, risk assessments, qualification records, change control, product testing data, and Deviation and CAPA management.
Your responsibilities
- Monitor and improve compliance and audit preparedness across departments.
- Maintain, and review trackers for routine processes such as EPD/NPD integration, Good For Sale (GFS) certification creation, microbiological testing, SOP periodic review, CAPA completion, internal audits, and internal and external non-conforming material holds.
- Communicate and work with SMEs on site to document the execution of Corrective and Preventative Actions (CAPAs).
- Document the development and implementation of Quality Improvement Plans (QIPs).
- Generate reports on QMS KPIs (percentage overdue actions, electronic form completion rates, documents pending periodic review, end-to-end FMEA risk ratings, etc.)
- Assist with the creation and revision of department procedures and work instructions through the DMS.
- Ensure major projects and Critical Events are properly recorded in the QMS as they occur.
- Collaborate with other departments to maintain and comply with site GMP requirements.
- Train action owners on basic QMS systems as needed
The experience we're looking for
- Must be proficient with computers, software, and data processing.
- Able and willing to work more than 40 hours per week, when the business needs additional support.
- Must be able to stand and walk for up to 4 hours at a time.
- Work is indoors and temperatures are seasonably normal for factory/production operations.
- Proper use of PPE is required daily when passing through or working in factory areas.
- Bachelor’s Degree in a Quality or STEM field required.
- Minimum 2 years of relevant work experience in manufacturing/operations Quality.
- Able and willing to work overtime, when the business needs additional support.
- Must have clear communication skills and command of English, both verbal and written.
- Continuously learn, keeping skills up to date with both industry and company changes.
- Maintain and exceed standards of compliance with internal and external requirements, as verified through audits.
The skills for success
Collaboration, R&D knowledge, Business Partnership, Process Improvement
What we offer
Equality