QA Documentation Specialist - II

At Proclinical, we are seeking an individual to fill the role of QA Documentation Specialist - II, based in Foster City, CA.

Job Responsibilities

• Analyze Change Requests (CRs) for completeness.
• Assist with the correct and timely implementation of documentation to support filings, projects.
• Interact with appropriate departments to establish project priorities and deadlines.
• Revise SOPs and work instructions for continuous improvement of documentation systems.
• Coordinate the distribution and maintenance for GXP documentation.
• Provide support to internal and regulatory audits/inspections as required.
• Perform administration of the Quality Management System in support of GXP documentation.
• Support the generation of monthly document control metrics.
• Participate in the development of training materials.
• Identify areas for improvements and propose changes to management.
• Perform advanced word processing tasks.

Skills And Qualifications

• High school diploma or BS in related field, and 4-6 years of relevant experience.
• Advanced understanding of the current pharmaceutical industry and applicable regulations.
• Demonstrate advanced working knowledge of Document Control fundamentals, knowledge of the process, effects, and the relationship between the document change process and products.
• Demonstrate advanced working knowledge of Quality Systems fundamentals.
• Demonstrate general working knowledge of Electronic Document Management Systems (EDMS).
• Advanced knowledge of Microsoft Office suite and computer systems that support document control processes.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Christopher Frank at (+1) 2674056996 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.