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Miles
Km80.5

Documentation Specialist

Sunesis Pharmaceuticals, Inc.

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Location: South San Francisco, CA Posted Date: 4/17/2013 Position Type: Full time Job Code: 1210 Required Education: Associates Degree Areas of Expertise Desired: Quality Assurance

Description

This position is responsible for the administering Quality Systems and the document control function for the Quality, CMC, and Clinical departments, including maintaining, filing and tracking, procedures, specifications, master records, supplier files, batch records, study protocols and reports, and trial master files.

Responsibilities include, but are not limited to:
•   Administers and supports quality systems (e.g. change control, deviations, documentation systems, CAPA, vendor control, training)
•   Maintains and administers Document Control and Change Control logs and databases
•   Responsible for access and security of Controlled Records Rooms and off-site storage
•   Establishes file naming conventions and standards for file structure hierarchies and document formatting
•   Provides support for PAI/NDA submission activities
•   Prepares document requests during regulatory inspections

Requirements

•   BS/BA degree and a minimum of 2 years of related experience or an AA degree with a minimum of 4 years of related experience
•   Proficient in MS Word, Excel, Outlook, PowerPoint and Adobe Acrobat
•   Familiarity with FDA regulations (e.g. GMP, GLP, GCP) preferred
•   Ability to recognize deviation from accepted practice and to exercise judgment in resolving routine problems
•   Detail oriented, ability to manage multiple projects simultaneously
•   Ability to work independently
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