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Miles
Km80.5

QA Document Control Administrator

Raptor Pharmaceuticals

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Location: Novato, CA Posted Date: 4/30/2013 Position Type: Full time Job Code: QADocControlAdmin Required Education: Bachelors Degree Areas of Expertise Desired: Quality Control

Description

Summary Description
The QA Document Control Administrator is responsible for maintaining the QA document management system, assembling and reviewing documents for, batch release, document control, change control, supplier qualification, deviations and CAPAs, C of As, and other QA documents as required.  This includes electronic organization and maintenance of critical document and records.

Responsibilities

•Maintain a QA document control management system compliant with cGMP regulations and Raptor procedures.
•Maintain status reports of lots, deviations, SOPs, CAPAs, supplier approvals, etc.
•Improve and manage organization in the Quality Assurance physical and electronic filing systems.
•Support data collection for annual product previews, management review, and regulatory inspections.
•Coordinate document numbering and index systems.
•Provide document tracking support for contract manufacturing sites and European Qualified Persons document and records.
•Track due dates for actions supporting lot release, deviations, CAPAs and procedures.
•Format and route standard operating procedures for review and approval.
•Maintain current revisions of procedures available for use. Archive and/or obsolete procedures in a controlled manner.

Requirements

Requirements
•Excellent computer proficiency skills required, including: Microsoft WORD/Excel, & Adobe Acrobat.
•Ability to work independently and create solutions for document management opportunities.
•Very strong communication and organizational skills.
•Good time management skills.
•Previous experience maintaining regulated/controlled records/data.
•Bachelor’s degree preferred.
•2 years’ experience in GxP pharmaceutical or medical device document control preferred.

Relocation not provided.

Please submit your resume and cover letter to careers@raptorpharma.com. Please include the job title in the subject line of your email.
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