Senior Quality Systems Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP)
  3. United States
Redwood City, USA
Posting date: 22 Jun 2020
QA.CN.30159

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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