Quality Specialist II

Job description

Johnson & Johnson Family of Companies touches more than a billion people's lives each 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 supports identified aspects of compliance related to products manufactured at the McNeil Consumer Healthcare Guelph Campus. You enable quality assurance activities that support product launch, product approval, post launch changes and document management processes; assist in the management, development and implementation of processes/activities associated with EtQ Change Control, EDM Standard Operator Procedures (SOPs), Specification Management (TRU), SAP Master Data process and other document management processes.

Responsibilities:
• Responsible for administration, training and troubleshooting activities to support processes that use EtQ Change Control
• Collaborate with business partners to develop/improve processes that use EtQ, TRU EDM SOPs, and lead/facilitate the implementation phase
• Develop/revise SOPs, process training documents, Analytical and Microbial Test Procedures, Raw Material/Bulk/Finished Goods Specifications.
• Create/review technical documents
• Prepare and revise specifications for McNeil products to meet corporate, regulatory guidelines, and USP requirements
• Responsible for inputting/reviewing SAP Master Data (Quality Module information for SAP Material Masters)
• Prepare, revise and approve Inspection Plans within SAP
• Assist with Project Management activities
• Review and approval of test methods
• Assist with regulatory audit preparation activities
• Lead cost improvement processes with respect to daily meetings, performance boards, and process confirmation
• Participate on site taskforces
• Prepare Annual Product Quality Reviews for internal products. Host APQR meetings, as required.
• Assist with recruiting (e.g. Quality System Student position)
• Act as delegate for Quality Systems Leader, as needed

Desired profile

Qualifications :

Minimum of Bachelor degree in Life Sciences (e.g. Biology, Chemistry, Biochemistry or related discipline)

Minimum of 3-5 years' experience in a pharmaceutical manufacturing or Quality environment

Knowledge, Skills and Abilities:

o Strong computer skill and SAP system knowledge
o Good knowledge of GMP regulations
o Experience with Analytical and Microbiology Laboratory equipment and methods is an asset
o Ability to work with limited supervision and function effectively in a team environment is essential
o Good interpersonal and collaboration skills
o Excellent communication skills
o Demonstrated ability to organize and prioritize workload
o Excellent decision-making abilities

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.