Senior Quality System Specialist

1 week ago

Old Toronto, Ontario, Canada Johnson & Johnson Full time

Job Description - Senior Quality System Specialist W)

Senior Quality System Specialist W

Description

Johnson & Johnson is currently recruiting for a Senior Quality System Specialist This position will be located in Toronto, CA.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at .

This position is responsible for the support/ownership of the following Quality System Functions: Controlled Document Management, Records Management, GxP Training, Corrective Action/Preventative Action (CAPA), Deviation/Non-conformance Management, Internal/External Audit, and Change Control. Additionally, this role is responsible for data analytics and management that will help support the broader Janssen Canada commercial organization.

Major Responsibilities:

· Reviews and challenges Commercial Quality (CQ) processes to ensure continuous process improvements and lead associated implementation

· Training, onboarding, and oversight of Vendor work

· Super User for Document Management system TruVault including Community of Practice attendance

· Training System Business Learning Administrator including issue resolution and escalation

· SME for Document Management and Training; including procedural ownership and perform assessment for any new or revised process changes

· Provides audit readiness and ongoing audit support including any corrective actions

· Support/back up Quality Systems elements such as nonconformance, change control, internal audit including reviewing and approving quality records

· Develops/prepares and deploys training materials and programs to meet CQ organizational needs

· Acts as liaison for segment and function specific training

· Manage Global Quality Manual binder, and maintain the procedures list

· Provides input into addressing non-conformances through analysis and providing recommendations for solutions including development/implementation of corrective actions

· Collaborates with internal partners to ensure the consistency and efficiency of CQ training curricula and training systems

· Communicates changes to or the introduction of new controlled documents along with any required downstream document management and training activities

· Coaches/trains users of the document and training quality system processes

· Supports the implementation of various new/updated processes and tools

· Maintains current with training requirements related to any specialized role in the electronic systems used in training and document management (e.g. TruVault, Summit)

· Performs validation tests for Document and Learning Management Systems enhancement

· Manage Workbook Validation process, and provide support in Janssen Canada

· Track progress of quality system activities and follow up with issue owners to ensure completeness and suitability of actions prior to file closure. Ensures timely closure of actions

· Review trending results with management on a monthly basis for roll up to CAPA Review Board

· Assess health authority and internal standards/SOP updates and impact on processes/systems

· Act as Record Coordinator for CQ Canada as a liaison between the department and the Records and Information Management (RIM) program to support compliance with RIM requirements

· Oversight of job description/summary or experience maintenance in applicable repository

· Other duties and functions within Quality department as required

Qualifications

Education:

A minimum of a Bachelor's or equivalent University degree

Required:

· Minimum 3-5 years in quality systems role with current GxP experience

· Experience in a pharmaceutical importing/distributing environment, with preferred experience in a manufacturing environment.

Core/Technical competency requirements:

· Effective strategic thinking capabilities, driven by sense of urgency and focused on results

· Strong technical proficiencies in multiple systems including (but not limited to): SAP/ ETS Trackwise/Salesforce/MS Office/Learning Management tools and able to provide support to other users

· Working knowledge of Record Management, and Legal Hold

· Strong ability to negotiate and influence key stakeholders (internal & external)

· Demonstrates agility and adaptability in learning new technologies and business processes

· Excellent communication (verbal and written) and strong interpersonal skills

· Demonstrated sound judgment in dealing with risk on compliance matters

· Well defined problem solving and analytical skills

· Manage multiple priorities including owning and balancing project management in conjunction with daily work

· Superior attention to accuracy and details

· Ability to work and collaborate within a matrix environment

· Ability to work independently and in cross-functional team settings

· Understanding of validation requirements

· Promotes and uses the contribution of people with diverse ideas, perspectives and backgrounds

Other:

This position may require up to 10% domestic travel.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit ]

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive considerationfor employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin,or protected veteran status and will not be discriminated against on the basis of disability.andEqual Employment Opportunity Posters GINA Supplement.

If you are an individual with a disability, please check ourpage for information on how to request an accommodation.Disability Assistance

This site is governed solely by applicable U.S. laws and governmental regulations. Please see our. Use of this site constitutes your consent to application of such laws and regulations and to our. Your use of the information on this site is subject to the terms of our. You should view thesection and the most recent SEC Filings in thesection in order to receive the most current information made available by Johnson & Johnson Services, any questions or search this site for more information.Privacy Policy Privacy Policy Legal Notice News Investor Contact Us

#J-18808-Ljbffr

  • Senior Quality System Specialist

    1 week ago

    Old Toronto, Ontario, Canada Johnson & Johnson Full time

    Johnson & Johnson is currently recruiting for a Senior Quality System Specialist This position will be located in Toronto, CA. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and...

  • Senior System Safety Specialist

    1 week ago

    Old Toronto, Ontario, Canada WSP Full time

    The Opportunity:WSP is seeking a proficient Senior System Safety Specialist who will play a pivotal role in the planning, development, and maintenance of WSP's System Safety Management System for railway projects. The ideal candidate should be well-versed in creating System Safety Plans, Safety and Assurance Reports, and Safety Cases in accordance with the...

  • Senior Project Quality Specialist

    1 week ago

    Toronto, Ontario, Canada Johnson & Johnson Full time

    Johnson & Johnson is currently recruiting for a Senior Quality System Specialist At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.This position is...

  • Senior Data Specialist

    1 week ago

    Old Toronto, Ontario, Canada CBCRadio-Canada Full time

    Senior Data Specialist (Procurement) (Finance) (Hybrid)Job ID: 42525 Job Type: Full Time Category: Finance Educations:Posted: Location:Job Views: 4 USD Negotiable Job Description:Job information Job Description:Job information Senior Data Specialist (Procurement) (Finance) (Hybrid) from the Company CBC/Radio-Canada, this latest Senior Data Specialist...

  • Senior Oracle Integration Specialist

    1 week ago

    Old Toronto, Ontario, Canada TalentWorld Full time

    Seeking a seasoned Software Developer with 7+ years of SDLC expertise in Oracle technologies, particularly within the healthcare sector. Candidates with a proven track record in public sector projects are highly desired. Join our innovative team to drive cutting-edge solutions, leveraging your deep industry knowledge and technical prowess to make a tangible...

  • Senior Validation Specialist

    1 week ago

    Toronto, Ontario, Canada Quality Analytics Full time

    Strategic development and, in partnership with other internal stakeholders, implementation of marketing plans for Entyvio and other GI product(s) as defined by the business unit head. Provides strategic direction to the IBD marketing team and supports the Product Managers who develop and implement a highly effective, integrated and comprehensive Brand Plan,...

  • Payroll Specialist, Senior

    1 week ago

    Old Toronto, Ontario, Canada WilsonHCG Full time

    Direct message the job poster from WilsonHCGCompensation:$85,000 to $95,000/Annually + Vacation + Benefits + RRSPOur client, a leading consulting firm, is seeking a Senior Payroll Specialist to join their team. Reporting to the Accounting Manager, this role is responsible for maintaining the efficiency and accuracy of the payroll management system. Operating...

  • Senior Specialist

    1 week ago

    Old Toronto, Ontario, Canada TEEMA Solutions Group Inc. Full time

    TEEMA Solutions Group Inc. – Toronto, Ontario 7 days ago , from TEEMA Solutions Group Inc. Job Title:Senior Specialist - Cyber Service LeadJob ID:66852Location:Toronto, OntarioOverview:Our client, the City of Toronto is looking for a Senior Specialist - Cyber Service Lead to join theOffice of the Chief Information Security Officer. TheManager reports...

  • Senior Systems Administrator

    1 week ago

    Old Toronto, Ontario, Canada GlassHouse Systems Full time

    We are looking for a Senior Systems Administrator to join our Managed Services group in the Toronto office. This is a full-time hybrid position.The Senior Technical Linux Systems Specialist will participate in technical delivery of Managed Services to internal and external customers and participate in corporate infrastructure projects as needed.What you'll...

  • Salesforce Quality Assurance Analyst

    1 week ago

    Old Toronto, Ontario, Canada Quality Analytics Full time

    Hey there!We are looking for a skilled professional to join our team as a Quality Assurance Tester. Check out the requirements below:Must Have Skills:3+ years of hands on experience with ETL from a quality assurance and testing perspectiveOver 1 year of experience in Salesforce3+ years' experience in tools like Selenium, TestNG, Cucumber, Maven,...

  • Quality Management System

    1 week ago

    Toronto, Ontario, Canada Ergomed Full time

    Job DescriptionThe Quality Management System & Training Compliance Specialist plays a key role in:Managing the identification, investigation, and resolution of Quality Events, Corrective Actions/Preventative Actions, and Effectiveness Checks within a GxP Quality Management System.Offering support for various QM&C activities on a global scale, such as...

  • Senior Systems Testing/QA Specialist

    1 week ago

    Old Toronto, Ontario, Canada 2i Solutions, Inc Full time

    We have an excellent 10 months contract opportunity for a Senior Systems Testing/QA Specialist in Toronto.This is a hybrid role ( 3days onsite and rest remote)Must haves:• 8+ years of experience working as a Software QA Tester• 5+ years of experience testing a Commercial Off the Shelf (COTS) Application• Experience testing Oracle Siebel CRM application...

  • Systems Testing/QA Specialist, Senior

    1 week ago

    Toronto, Ontario, Canada Global Pharma Tek Full time

    Position: Systems Testing/QA Specialist - Senior Location: Toronto, ON (Hybrid) Duration: Business Days + Possible Extension Job Description: Testing: + years of experience in process, planning, organizing and implementing testing efforts. Extensive Experience with test management tools on one or more platforms such as Azure DevOps &...

  • Linux Systems and Support Specialist

    1 week ago

    Old Toronto, Ontario, Canada Sage Recruiting Inc. Full time

    Sage Recruiting is looking for a Linux Systems and Support Specialist (preferably senior level) to join a Toronto-based software company. The role is 3 days a week in the office, and 2 days a week remote. Our client is the leading provider of cloud-based asset management tools for media assets within the Film and TV industry and they're innovating digital...

  • Quality Specialist

    1 week ago

    Toronto, Ontario, Canada IFG International Financial Group Ltd Full time

    Our client, a large financial institution, is looking for a Quality Specialist for a 6-month contract located in Toronto. This is an excellent opportunity for a Quality Specialist with a financial services background. Please note this position is currently a hybrid work arrangement requiring 3 days in office. As a Quality Specialist your duties will...

  • Specialist Central Services

    1 week ago

    Toronto, Ontario, Canada Independent Electricity System Operator (IESO) Full time

    Specialist Central Services:Date:Jun 11, 2024Location:CACompany:Independent Electricity System OperatorINDEPENDENT ELECTRICITY SYSTEM OPERATOR (IESO)Requisition ID: 19845Location: Toronto, hybridStatus: RegularBusiness Unit: Planning, Conservation & Resource AdequacyWhy join us?You've got great skills. And you want to use them in an organization where you...

  • Senior Training Specialist

    1 week ago

    Old Toronto, Ontario, Canada Capleo Global Solutions Pvt Ltd Full time

    Position: Senior Training Specialist Location: Toronto, ON (Hybrid, 3 days WFO) Duration: 12 Months Contract (option for extension)Responsibilities Pls Note: Frequent travel is required. The resource will be required to travel to multiple dispatch centres/CACCs across the province to provide training on the new Telephony solution/Next Generation 911....

  • Systems Testing/qa Specialist

    1 week ago

    Toronto, Ontario, Canada Arthur Grand Technologies Inc Full time

    Arthur Grand Technologies is currently seeking a highly motivated and skilled Systems Testing/QA Specialist - Seniorfor one of our clients.Position: Systems Testing/QA Specialist - SeniorLocation: Toronto, Ontario (Hybrid)Duration: Long Term ContractExperience and Skill Set Requirements 7+ years of experience in system testing. Excellent knowledge of system...

  • Quality Specialist

    1 week ago

    Toronto, Ontario, Canada Stefanini, Inc Full time

    Stefanini is looking for a Quality Specialist in Toronto, Canada(Onsite Only)For Quick Apply, please reach out to Preeti Prabhakar-/ Continental 12 hour shifts. (6 AM-6 PM)HM is looking for the following:On-the-line/shop floor activities.Hold and release/control of non-conforming product. Regular line checks, metal detection checks and ATP swabbing....

  • Quality Assurance Specialist

    3 days ago

    Toronto, Ontario, Canada Adecco Canada Full time

    Quality Assurance Specialist Our client is a renowned leader in metal fabrication and machining, known for producing high-precision components and assemblies for various industries. Their commitment to quality and innovation has established their reputation as a trusted partner in the manufacturing sector. We are seeking a dedicated Quality Assurance...