In this role, the selected candidate will lead the business group's efforts to maintain and enhance the ISO 9001 systems by working with global quality, external registrars, and the sites serving as the group Management Representative.
Quality Assurance Specialist will be part of a team that is responsible for all Customer Support Services Training & Quality. This includes supporting our training initiatives for new hires and existing employees; and assisting to maintain training programs and all reference material.
In this role, you will be responsible for documentation quality review/approval or audits, documentation maintenance and archival, quality inspections of product, and participating on internal assessments.
In this role, you will be responsible to plans, leads and executes audits to verify execution of the technology strategy to help ensure that mrl systems, software and instruments meet mrl standards and regulatory requirements. Facilitate the implementation of the necessary processes and controls to achieve the strategy.
In this role, you will be responsible for supporting the Quality Management department with improvements through project planning, development and implementation, and the establishment of policies and procedures pertaining to the DMAHS, HEDIS and Medicare Star Program.
In this role, you will be responsible for
product Development, Facilities and Manufacturing to meet clinical project and product needs.Ensures that the quality assurance programs and procedures are adhered to and followed to ensure compliance to cGMP regulations and ICH guidelines.