HireDiversity

Guelph, ON, CA

Quality Compliance Specialist - Johnson & Johnson Inc - Guelph, ON-8487130131

Description

Johnson & 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 most 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 two manufacturing sites and two R&D facilities located in Guelph, Ontario and Montreal, Quebec.

Position Overview

To 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 System

Liaise with the Consumer Care Center

Manage/investigate assigned complaint files within defined timelines

Coordinate 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 appropriate

Evaluate complaint investigation reports

Collect, evaluate and report Quality Metrics for distribution to JJI Canada and J&J Global Consumer Quality & Compliance

Collect and evaluate data and generate Complaint reports for inclusion in Annual Product Quality Review reports for JJI Canada marketed products and McNeil - Guelph manufacturing

Manage Complaint samples (process, evaluate, coordinate investigations)

Provide support to McNeil Guelph-Site Complaint Coordinator/Investigator

Support Audit activities related to Complaint Vigilance

Create complaint data reports as requested by business partners

Participate in quarterly complaint review meetings as required

Represent Quality & Compliance on committees and projects as required

Assist in executing activities associated with CAPA and Change Control as required

Facilitate team interaction and foster team development

Identify and implement opportunities for innovation and continuous improvement of processes and systems

Contribute to a productive working relationship within Quality & Compliance, intra/interdepartmentally and external business partners

Develop/revise Complaint Vigilance Standard Operating Procedures, Process training documents

J2W:LI

Qualifications


EDUCATION AND EXPERIENCE:

Bachelor of Science in life sciences, chemistry or a related discipline is required.

Minimum 2-4 years experience in pharmaceutical, medical device, QA/Regulatory/R&D is required.

Sound knowledge of GMP/GLP, NHP, Medical Device and Cosmetics regulations is required

Proficiency with computer based programs including email, word processing, databases and business enterprise software is required

Knowledge of SAP and PQMS an asset.

Ability to take ownership for and work independently on project activities

Process Excellence experience is an asset

Excellent communication/presentation skills

Previous project management experience an asset

COMPETENCIES:

Results and Performance Driven

Ability to take ownership for and work independently with accuracy and high capacity output

Ability to manage and prioritize day to day activities and projects

Interdependent Partnering

Decision Making

Masters Complexity

Strong verbal and written communication skills

Collaboration and teaming

BE 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.

Primary Location:North America-Canada-Ontario-Guelph
Organization: Johnson & Johnson Inc. (7695)
Job Function: Compliance