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Senior Project Quality Specialist
3 months ago
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 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.
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; 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. Performs validation tests for Document and Learning Management Systems enhancement
~ Track progress of quality system activities and follow up with issue owners to ensure completeness and suitability of actions prior to file closure.
Other duties and functions within Quality department as required Education:
A minimum of a Bachelor's or equivalent University degree
Minimum 3-5 years in quality systems role with current GxP experience
~ Core/Technical competency requirements:
~ 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
~ Demonstrated sound judgment in dealing with risk on compliance matters
~ Manage multiple priorities including owning and balancing project management in conjunction with daily work
~ This position may require up to 10% domestic travel.
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.
