Quality Validation Specialist Ii - Guelph, Canada - Johnson & Johnson

Johnson & Johnson

Verified Company

Guelph, Canada

1 week ago

Posted by:

Sophia Lee

beBee Recruiter

Description

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.

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.

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 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.

Other responsibilities:

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

Qualifications:

Required qualifications:

Minimum University/Bachelors Degree or Equivalent in Science / Engineering or related discipline
Minimum 24 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.
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.

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.