Senior Quality Systems Specialist job in Redwood City, USA

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First Name*

Last Name*

Email*

Phone Number*

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP)

Location: United States

This vacancy has now expired. Please see similar roles below...

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.

Job Responsibilities:

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.

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