Regulatory Compliance Specialist for Diagnostic Testing
2 settimane fa
Overview
Cepheid, a Danaher company, is dedicated to improving healthcare through fast and accurate diagnostic testing. We are passionate about developing scalable solutions that address the world's most complex health challenges.
Salary and Benefits
The estimated annual salary for this role is $65,696-$87,092 based on a 12-hour shift with an alternating 3-day/4-day work schedule in Lodi, California.
About the Role
This Quality Assurance Specialist II position will be responsible for reviewing records to ensure compliance with QSR and ISO requirements. The ideal candidate will have experience in DNA diagnostics or medical devices and excellent communication skills.
Key Responsibilities
- Collaborate with the manufacturing department for scheduling line clearance and setup activities.
- Review electronic documentation for completeness and compliance with regulatory requirements.
- Develop standard operating procedures to define and improve quality system functions.
- Support the Material Review Board for non-conforming materials and closure of Non-conformance and Deviation Reports.
- Lead interdepartmental initiatives for continuous improvement.
Requirements
- A minimum of 2-4 years of relevant experience in scientific, quality system, or related discipline.
- High school diploma or equivalent with practical experience in a regulated manufacturing environment.
- Familiarity with ISO standards and applicable regulatory requirements (CE/FDA/QSR) and GDP.
Bonus and Incentive Pay
This role is eligible for bonus/incentive pay, offering additional opportunities for career growth and development.
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