What are the responsibilities and job description for the Senior Quality Specialist- Post Marketing position at Cynet Systems?
Job Description :
Pay Range : $40hr - $45hr
Responsibilities :
- Performs Global Regulatory Impact Assessment (GRIA) for North America and serves as coordinator to all other regions / countries for GRIA completion maintaining all regional documentation in the field action file.
- ssists in preparation of distribution reports as needed for field action preparation
- Support MMS field action team in customer letter drafting, gathering stakeholder feedback, and finalization.
- Maintains the "official record" field action file, ensuring all documentation is complete and appropriately filed in accordance with department standards to facilitate easy retrieval for audit support.
- Tracks recall activities to closure and prepares the final closure documentation for each field action file.
- Compiles field action data in support of MMS Management Reviews.
- Ensures all SharePoint data is complete for metric reporting.
- Provides documents in support of MMS audits as needed.
- Manages data requests from other departments for field action activities.
- Manages MMS-related Canadian recall-related activities within the NA PMQ organization, including customer letter creation, review, and finalization.
- Participates in post-market surveillance data review meetings as needed in support of MMS field action activities.
- Serve as a team member and / or leader on projects for the department as assigned.
- Supports revisions to policies and procedures related to the MMS field action process as needed.
- Participates in the development, review, issuance, and training of Client policies and procedures related to Post Market Quality.
- Develops solutions to routine assigned activities of moderate scope and complexity
- This position has no direct reports and must accomplish tasks through cooperation with other Regulatory, Quality, Medical, Operations, and R&D professionals worldwide.
- bility to support business needs for Pacific Standard Time (PST).
Qualifications :
Preferred Experience And Education :
Salary : $40 - $45
