Johnson & Johnson Careers
Quality Specialist II
Requisition ID: 8267181127
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 Validation Services Team is responsible for maintaining compliance-based systems used in the manufacturing and packaging of products at the Johnson & Johnson Guelph Campus. The Validation Specialist 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 the required specifications, comply with Johnson & Johnson policies, quality standards, health, safety and environmental regulations, and regulatory requirements.
As a member of the Plant Quality Team, your major responsibilities include:
•Review, revise and approve validation documents (i.e. assessments, protocols, reports etc.) to ensure that they are in compliance with relevant Standard Operation Procedures (SOPs), government regulations and company policies. Validation types include packaging validation, cleaning validation, process validation, analytical and microbial method validation, equipment qualification and computerized system validation.
•Preparation and maintenance of validation policy documents, validation specifications and validation SOPs to ensure compliance with regulatory governing bodies (Health Canada and the United States FDA), company requirements (Johnson & Johnson Group of Consumer Companies Canada), quality standards and industry trends.
•Provide consultation to business partners in order to support process changes, new equipment or system introductions, technical transfers and product launches.
•Evaluate the impact of modifications to processes, methods, equipment or systems to figure out extent of validation required.
•Prepare validation assessment reports in support of the site Annual Product Quality Review process.
•Complete all delegated change control tasks in a timely manner.
•Maintain all validation documents in a controlled state; hardcopies properly filed in the documentation room and electronic copies saved in the applicable secure file location, duly administered through the document-tracking databases and scanned folders.
Education and experience:
•Minimum of a degree or diploma in Science/Engineering or a related discipline or equivalent experience within the chemical/ pharmaceutical industry.
•At least 3 years experience in the pharmaceutical industry within Quality Assurance, Pharmaceutical Research & Development, or Plant Operations.
•Knowledge of Good Manufacturing Practices regulations.
•Experience with Process Excellence an asset.
COMPETENCIES AND SKILLS:
•Integrity and Credo based actions
•Big picture orientation
•Organization and talent development
•Sense of urgency
•Prudent risk taking
•Self awareness and flexibility
•Results and performance driven
•Strong computer skills specifically in Microsoft Word, PowerPoint, Excel and Adobe Acrobat
•Strong technical writing, verbal communication, social, and analytical skills
•Other key skills include attention to detail, being able to work effectively within a team and as an individual, and able to effectively prioritize tasks.
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.
Johnson & Johnson Inc. (7695)