Senior Quality Systems Specialist
Proclinical is currently recruiting for a Senior Quality Systems Specialist with a pharmaceutical company located in Redwood City, CA. A successful candidate will have experience with deviations and CAPAs, have a bachelor's degree or higher, and excellent communication skills.
- Performs a wide variety of activities to ensure compliance with applicable regulatory requirements
- Participates in developing Standard Operating Procedures to ensure quality
- Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs)
- Independently conduct, complete, and document critical, major, and minor investigations related to GxP operations
- Facilitate cross-functional meetings with internal and external parties as required
- Apply Root Cause Analysis tools to identify root causes and propose effective corrective and preventive actions
- Supports management and tracking of quality system records (i.e. Deviation Reports, Corrective and Preventive Actions, and Effectiveness Checks) for adherence to organizational or departmental targets
- Responsible for maintaining tracking tools/databases
- Responsible for sending periodic reminder notifications to leads/coordinators
- Supports management review process through development and generation of quality system metrics and trending, and escalate issues as required
- Supports the maintenance and improvement to quality systems processes, as needed
- Works directly with operating entities and internal clients to ensure follow-up of quality issues
- Participate in the development of training programs regarding all aspects of producing quality products, as required
- Assist compliance audits as required
- Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed
Skills and Requirements:
- Excellent Communication Skills
If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.