Quality Systems Specialist II (15 month contract)

Kenvue Inc.; Guelph; On-site; CAD 61,000 - 97,000; Full time

Benefits offered by this job

Competitive Benefit Package

Paid Company Holidays, Paid Vacation,–

Learning & Development Opportunities

Kenvuer Impact Networks

Job summary

Kenvue is seeking a Quality Systems Specialist II on a 15 month contract in Guelph, Ontario to support quality laboratory systems, compliance activities, and equipment qualification. You will manage laboratory systems data (Empower, etc.), perform system administration, and assist with validation documents and lifecycle activities.

This role requires 3–5 years in quality systems or lab operations, strong communication, analytical and problem-solving skills, and experience with Empower, Biovia

Qualifications

• Bachelor’s degree or equivalent in a relevant field.
• 3 to 5 years of experience supporting quality systems, laboratory operations, or related experience.
• Strong communication skills to effectively translate technical quality concepts.
• Excellent analytical and problem-solving skills.
• Proficient with computer applications and systems, including laboratory and quality management tools.
• Experience with Analytical and Microbiology Laboratory equipment, methods, and testing processes.
• Strong technical writing skills, including the ability to develop and maintain clear, accurate, and compliant documentation.
• Experience with laboratory software especially Empower, Biovia LES and Labware LIMS is strongly preferred.
• Practical and theoretical knowledge and experience with instrumentation troubleshooting (such as HPLC, UPLC, UV-VIS, FTIR)
• Experience with Equipment and Software Qualification
• Previous laboratory system administration experience is an asset
• Ability to work independently and as part of a team
• Strong verbal and written communication skills, with the ability to engage and influence stakeholders
• Excellent project management and prioritization capabilities
• Demonstrate problem solving and multitasking capabilities
• Enjoys working to multiple deadlines in a dynamic and fast-paced team

Responsibilities

• Support compliance activities related to quality laboratory systems, computer system validation, ensuring adherence to quality and regulatory requirements, including supporting successful regulatory and audit activities.
• System administration including user access and audit trail reviews, equipment and software qualification and validation documents (protocols, reports, validation assessments, technical reports), troubleshooting, and laboratory equipment lifecycle management.
• Perform master data setup and maintenance within laboratory systems (e.g., Empower) to enable laboratory testing, product release, product launches, product approvals, and post-launch changes.
• Develop, execute, and maintain equipment and software qualification and validation documentation, including protocols, reports, validation assessments, and technical reports.
• Provide technical troubleshooting and support for laboratory computer systems, equipment, and applications.
• Manage laboratory equipment throughout its lifecycle, including qualification, maintenance, compliance, and retirement activities.
• Support quality laboratory equipment programs to ensure continued reliability, performance, and regulatory compliance.
• Facilitate External Contractor/Vendor visits and request for troubleshooting and qualification activities

Skills

Strong communication skills

Analytical and problem-solving

Proficient with computer applications

Experience with lab equipment

Education

Bachelor’s degree or equivalent in a relevant field

Tools

Empower

Biovia LES

Labware LIMS

Job description

Kenvue is currently recruiting for a: Quality Systems Specialist II (15 month contract)

What we do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.

Role reports to

Compliance Lead

Location

North America, Canada, Ontario, Guelph

Work Location

フルオンサイト

What you will do

The Quality Systems Specialist II – Technical Services supports identified aspects of compliance related to products manufactured. To enable quality assurance activities that support quality laboratory testing and release programs, product launches, product approval, post launch changes and quality laboratory equipment programs. The role assists in the management, development and implementation of processes/activities associated with quality laboratories computer systems, equipment, and applications. Master data set up (Empower, etc.), systems administration including user access and audit trail reviews, equipment and software qualification and validation documents (protocols, reports, validation assessments, technical reports), troubleshooting, and laboratory equipment lifecycle management.

Key Responsibilities

• Support compliance activities related to quality laboratory systems, computer system validation, ensuring adherence to quality and regulatory requirements, including Supporting successful regulatory and audit activities
• System administration including user access and audit trail reviews, equipment and software qualification and validation documents (protocols, reports, validation assessments, technical reports), troubleshooting, and laboratory equipment lifecycle management.
• Perform master data setup and maintenance within laboratory systems (e.g., Empower) to enable laboratory testing, product release, product launches, product approvals, and post-launch changes.
• Develop, execute, and maintain equipment and software qualification and validation documentation, including protocols, reports, validation assessments, and technical reports.
• Provide technical troubleshooting and support for laboratory computer systems, equipment, and applications.
• Manage laboratory equipment throughout its lifecycle, including qualification, maintenance, compliance, and retirement activities.
• Support quality laboratory equipment programs to ensure continued reliability, performance, and regulatory compliance.
• Facilitate External Contractor/Vendor visits and request for troubleshooting and qualification activities

What we are looking for

Required Qualifications

• Bachelor’s degree or equivalent in a relevant field
• 3 to 5 years of experience supporting quality systems, laboratory operations, or related experience.
• Strong communication skills to effectively translate technical quality concepts
• Excellent analytical and problem-solving skills
• Proficient with computer applications and systems, including laboratory and quality management tools.
• Experience with Analytical and Microbiology Laboratory equipment, methods, and testing processes.

Desired Qualifications

• Strong technical writing skills, including the ability to develop and maintain clear, accurate, and compliant documentation.
• Experience with laboratory software especially Empower, Biovia LES and Labware LIMS is strongly preferred
• Practical and theoretical knowledge and experience with instrumentation troubleshooting (such as HPLC, UPLC, UV-VIS, FTIR)
• Experience with Equipment and Software Qualification
• Previous laboratory system administration experience is an asset
• Ability to work both independently and as an integral member of the team
• Strong verbal and written communication skills, with the ability to engage and influence stakeholders at various levels.
• Excellent project management and prioritization capabilities
• Demonstrate problem solving and multitasking capabilities
• Enjoys working to multiple deadlines in a dynamic and fast-paced team

What’s in it for you

Annual base salary for new hires in this position ranges:$61,000.00 - $97,175.00

This takes into account a number of factors including work location, the candidate’s skills, experience, education level & other job-related factors.

• Competitive Benefit Package*
• Paid Company Holidays, Paid Vacation, Volunteer Time & More!
• Learning & Development Opportunities
• Kenvuer Impact Networks
• This list could vary based on location/region

*Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.

Kenvue incorporates Artificial Intelligence into our recruitment process to enhance job postings and streamline the sorting and screeningofapplications, helping attract a qualified candidate pool. Our experienced team will review and select the top applicants, ensuring that human judgment guides our hiring decisions. For more information, please refer to our Careers Privacy Policy.

Vacancy: This job posting is for an existing, currently vacant position.