Senior Quality Assurance Specialist
4 weeks ago
As a Senior Quality Assurance Specialist at Ampcus, you will be responsible for administering a compliant and effective Quality Management System (QMS) for the activities in scope. This includes enabling the transition/deployment of the Process Quality Management System (PQMS) and managing its deployment. You will ensure proper audit planning and scheduling meets the requirements of internal policies and external regulations.
Key Responsibilities:
- Locally manage plans for all QMS parts in scope while maintaining a compliant and effective (local) QMS throughout the duration of the transition to the PQMS.
- Administer and contribute to the management of any local QMS documents in line with the evolution of the PEQS and PQMS.
- Support training and training administration as the QMS and contribute to training content for local QMS documents as necessary.
- Contribute to the availability of metrics/KPI data to measure training effectiveness, PQMS deployment, and QMS compliance.
Requirements:
- High School diploma.
- Minimum of three years of similar work experience.
- Experience working in disciplined regulated industry and applying automated technology.
- Familiar with process management methodologies and practices.
Working Conditions:
- Position is Remote, CW located on East Coast.
- Ensures compliant and effective QMS are established in scope.
Regulatory Compliance:
- 21 CFR.
- ISO 9001.
- Medical Device documentation and QA planning (2+ yrs and 4+yrs).
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