Quality Validation Specialist II -24-month contract - #8985820
Johnson & Johnson
Johnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Validation Specialist II -24-month contract to be based in Guelph, Canada.
Johnson & Johnson Family of Companies touches more than a billion people’s lives every single day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and OTC products.
Are you interested in joining a team that is helping improve patient and customer care and drive innovation? Apply today!
Johnson & Johnson announced plans to separate our Consumer Health business to create a new publicly traded company. The process of the planned separation is anticipated to be completed within 24 months, and it will be subject to legal requirements including consultation with works councils and other employee representative bodies, as required, and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of a new entity within New Consumer Health and your employment would be governed by New Consumer Health’s employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by New Consumer Health at an appropriate time and subject to any necessary consultation processes.
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 validations 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 Johnson & Johnson and McNeil 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 Johnson & Johnson Consumer and OTC North American stakeholders to develop and administer validation policies, including the deployment of these policies.
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 McNeil Consumer Healthcare – 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 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, Bill of Materials, SOPs etc.
- Guidance/Training on Quality Validation review and approval
- Guidance/Training to employees on Technical Writing
- Provide Q&C support to validation, production and process investigations, including the identification of novel solutions to complex problems in the manufacturing environment
- Provide support to JJOS / Continuous Improvement Projects
- Minimum University/Bachelors Degree or Equivalent in Science / Engineering or related discipline
- Minimum 2-4 years experience within the chemical / pharmaceutical industry.
Required knowledge, skills and abilities:
- 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.
- Advanced computer skills, specifically in Microsoft Word, Excel, and Adobe Acrobat.
- Strong technical writing, verbal communication, interpersonal and problem solving skills.
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of full COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.