Quality Specialist II

Cosa facciamo

A Kenvue, ci rendiamo conto dello straordinario potere della cura quotidiana. Costruiti su oltre un secolo di tradizione e radicati nella scienza, siamo la casa di marchi iconici, tra cui NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® e BAND-AID® che già conosci e ami. La scienza è la nostra passione; la cura è il nostro talento.

Chi siamo

Il nostro team globale è composto da ~ 22.000 persone brillanti con una cultura del posto di lavoro in cui ogni voce conta e ogni contributo è apprezzato. Siamo appassionati di intuizioni, innovazione e impegno a fornire i migliori prodotti ai nostri clienti. Con competenza ed empatia, essere un Kenvuer significa avere il potere di avere un impatto su milioni di persone ogni giorno. Mettiamo le persone al primo posto, ci prendiamo cura di noi, ci guadagniamo la fiducia della scienza e risolviamo con coraggio - e abbiamo brillanti opportunità che ti aspettano! Unisciti a noi per plasmare il nostro futuro e il tuo. Per ulteriori informazioni, fare clic su here.

Role riporta a:

Supervisor II, Validation

Ubicazione:

North America, Canada, Ontario, Guelph

Luogo di lavoro:

Completamente in loco

Cosa farai

Kenvue is currently recruiting for:

Quality Specialist II (Validation) – 18 month contract

This position reports to the Supervisor II Validation and is based at Guelph, ON, Canada.

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: Supervisor II Validation

Location: Guelph, ON, Canada

Travel %: 0

Pay: Level 24

What you will do 

The Quality Specialist II (Validation) will support and co-ordinate activities associated with cleaning, manufacturing and packaging processes, computer systems, analytical and microbial method, shipping, facility, utility and equipment qualifications for the Guelph site.

The Quality Specialist II will coordinate the development, creation, review and approval of qualification and validation documents (protocols, reports, validation assessments, technical reports, and user requirements, function and design specifications).

They will ensure that documented evidence exists to provide a high degree of assurance that processes, equipment, computer systems and methods are consistently reproducible and meet Kenvue policies and quality standards, health, safety and environmental regulations, and regulatory requirements (e.g. Health Canada and the United States FDA).

The Quality Specialist II will collaborate with stakeholders to develop and administer validation policies, including the deployment of these policies

Key Responsibilities

• Review, revise or approve validation documents (ie. assessments, documents, protocols, reports, etc.) to ensure they are in compliance with relevant SOPs, government regulations, and company policies.  This includes documents executed at Kenvue – Guelph Campus and /or specific business partners and contract sites.  Validation types may include but are not limited to: packaging validation; cleaning validation; process validation; analytical and microbial method validation; shipping qualification; equipment qualification; and computer validation.

• Represent Quality & Compliance on taskforces / committees for base business, new product introduction and capital projects. Connect with SMEs as appropriate to ensure transfer of knowledge and action on key deliverables.

• Create, review and/or approve other site documents, such as: GCC assessments, Annual Product Quality Reports (APQR), Master Batch Records, SOPs etc.

What we are looking for

Required Qualifications

• Minimum degree in Science/Engineering or related discipline

• Minimum 3-5 years of relevant experience in Quality, R&D or Production environment in the pharmaceutical industry.. Validation experience in the pharmaceutical industry an asset.

• Ability to evaluate scientific data.

• Ability to take ownership for work independently on project activities.

• Excellent communication and presentation skills.

• Knowledge of and competence in the application of Health Canada GMPs, CFRs and ICH Guidelines.

• Must be able to influence and facilitate groups with diverse perspectives and bring teams to consensus / alignment.

• Strong leadership, organization, decision making and interaction management skills.

• Strong computer skills, specifically in Microsoft Word, Excel, and Adobe Acrobat.

• Strong technical writing, verbal communication, interpersonal and problem solving skills.

What’s in it for you

• 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.

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