Plant Quality Specialist II

Plant Quality Specialist II

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:

Plant Quality Supervisor II

Location:

North America, Canada, Ontario, Guelph

Work Location:

Fully Onsite

What you will do

The Plant Quality Specialist II is responsible for reviewing batch record documentation related to the manufacturing and testing of bulk work-in-process and finished products to ensure compliance with internal specifications, regulatory requirements, and corporate quality standards. This role performs batch release activities, including usage decisions in SAP, and generates Certificates of Compliance and Certificates of Analysis.

 

The position provides quality oversight and shop floor support to Operations, including approval-to-proceed activities and quality assessments within CMMS. The Plant Quality Specialist II partners with cross-functional teams to support quality event investigations using Root Cause Problem Solving (RCPS) principles and drives continuous improvement initiatives that enhance compliance, product quality, and operational effectiveness.

 

Additional responsibilities include conducting quality audits and inspections of production activities, such as Standards of Cleanliness audits, logbook reviews, and inspector certification programs. This role is expected to be cross-trained across all batch record review processes.

 

This position supports the first shift (7:00 AM to 3:00 PM), and candidates must be available to work the assigned schedule.

 

Key responsibilities:

• Responsible for review and approval of Batch Record documentation, creation of CoA / CoC, communication of review/release priorities with key stakeholders, completion of monthly logbook audits.
• Responsible to support Processing and Packaging areas to ensure compliance internal specifications, regulatory and corporate policies, and work with business partners to support investigation of quality events
• Act as a Qualified Trainer.
• Act as a Subject Matter Expert in Record Retentions, or in Regulatory audits.
• Proactively engage with both Quality and Operations teams to identify compliance risks, implement solutions, improve Kenvue culture of compliance and audit readiness
• Identify and implement continuous improvement projects that evolve Quality and Compliance approaches, improve documentation and process first time right, and reduce batch release cycle times

 

Qualifications

Required:

• Minimum of a Bachelor’s Degree in Science or related disciplines·        
• Minimum of 3-5 years relevant experience in a Quality, or Operations environment in the pharmaceutical, food or water industries·        
• Experience with pharmaceutical GMPs, processes or equipment
• Strong digital literacy and some SAP, Pas-X system knowledge
• Experience with batch record/ documentation review

Preferred:

• Excellent interpersonal, teamwork, and collaboration skills
• Demonstrated ability to organize and prioritize workload
• Enjoys working to multiple deadlines in a dynamic and fast-paced team environment
• Strong technical writing, verbal communication, and problem-solving skills
• Process Excellence/Lean certification

Other:

• The Quality Specialist II (Plant Quality) will work with their computer every day on an almost continuous basis
• They will need to be able to sustain their visual focus and concentration for extended periods
• Lifting or moving objects >25Ibs/10Kg in weight might be required
• Some shift flexibility and the ability to work overtime might be required 

#LI-KL1

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.

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.

Kenvue incorporates Artificial Intelligence into our recruitment process to enhance job postings and streamline the sorting and screening of applications, 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.