Quality Compliance Specialist (24 Month Contract, Part-Time, Monday to Friday) Job

Job description

Quality Compliance Specialist (24 Month Contract, Part-Time, Monday to Friday)-0686150707DescriptionJohnson & Johnson Inc. is a member of the Johnson & Johnson Family of Companies, the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. In Canada, Johnson & Johnson Inc. markets innovative consumer products focusing on skin and hair care, baby care, wound care, oral health and women's health as well as a broad range of well-known and trusted over-the-counter products through our McNeil Consumer Healthcare division.
At Johnson & Johnson Inc. our purpose is to "Bring Science to the Art of Healthy Living" by providing Canadians with some of the world's most widely used and trusted brands including; JOHNSON'S ® Baby, NEUTROGENA®, AVEENO® LISTERINE®, BAND-AID® Brand Adhesive Bandages, TYLENOL®, REACTINE® , BENYLIN® , NICORETTE®, NICODERM® and many more. Based in Markham, Ontario, Johnson & Johnson Inc. employs approximately 400 people and is supported by a manufacturing and R&D facility located in Guelph, Ontario.
The Quality Compliance Specialist (Part-Time, 24 Month Contract) will support compliance related to the Complaint Management Process for products marketed by Johnson & Johnson Inc., Canada (JJI). To enable quality assurance activities related to complaint vigilance in support of product quality complaints, including; complaint file review, data review, trending and report generation. To manage, develop, and implement processes improvements/activities associated with complaints, complaint sample management, Product Quality Management System (PQMS) and to complete special projects as assigned.
MAJOR RESPONSIBILITIES:Execute review of consumer complaints upon receipt in the Canadian Product Quality Management SystemLiaise with the Consumer Care CenterManage/investigate assigned complaint files within defined timelinesCoordinate investigations related to product quality complaints with J&J Affiliates, J&J Consumer Care Center, JJI Medical Safety team, external manufacturers, suppliers and laboratories and escalates as appropriateEvaluate complaint investigation reportsCollect, evaluate and report Quality Metrics for distribution to JJI Canada and J&J Global Consumer Quality & ComplianceCollect and evaluate data and generate Complaint reports for inclusion in Annual Product Quality Review reports for JJI Canada marketed products and McNeil – Guelph manufacturingManage Complaint samples (process, evaluate, coordinate investigations)Provide support to McNeil Guelph-Site Complaint Coordinator/InvestigatorSupport Audit activities related to Complaint VigilanceCreate complaint data reports as requested by business partnersParticipate in quarterly complaint review meetings as requiredRepresent Quality & Compliance on committees and projects as requiredAssist in executing activities associated with CAPA and Change Control as requiredFacilitate team interaction and foster team developmentIdentify and implement opportunities for innovation and continuous improvement of processes and systemsContribute to a productive working relationship within Quality & Compliance, intra/interdepartmentally and external business partnersDevelop/revise Complaint Vigilance Standard Operating Procedures, Process training documentsQualificationsEDUCATION AND EXPERIENCE:Bachelor of Science in life sciences, chemistry or a related discipline is required.1-3 years experience in pharmaceutical, medical device, QA/Regulatory/R&D is preferred.
Sound knowledge of GMP/GLP, NHP, Medical Device and Cosmetics regulations is preferred.
Proficiency with computer based programs including email, word processing, databases and business enterprise software is requiredKnowledge of SAP and PQMS an asset.
Ability to take ownership for and work independently on project activitiesProcess Excellence experience is an assetExcellent communication/presentation skillsPrevious project management experience an assetCOMPETENCIES:Results and Performance DrivenAbility to take ownership for and work independently with accuracy and high capacity outputAbility to manage and prioritize day to day activities and projectsInterdependent PartneringDecision MakingMasters ComplexityBE VITAL in your career; Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
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.
J2W: LI NAPrimary Location:North America-Canada-Ontario-GuelphOrganization: Johnson & Johnson Inc. (7695)Job Function: Compliance