Document Control Manager

About The Company

 

Aviir is a venture-funded biotechnology company based in Palo Alto, CA developing cutting-edge, convenient diagnostic tests that enable accurate diagnosis of cardiovascular disease.  The company?s proprietary technology is based on many years of research at Stanford University, and combines the scientific founders? deep understanding of disease marker proteins and advanced biostatistics.  The company is currently pursuing a highly aggressive commercialization strategy, with its initial products expected to reach the market by 3Q 2008.  The current team consists of the founding scientists and a highly experienced management team.

 Opportunity and Responsibilities

This position will report to the Director of Quality Assurance/Quality Control and be responsible for the Document Control function in a medical device (IVD) GMP/ISO/CLIA environment.  This will include organization and retention of controlled documents, and facilitation of controlled document change and approval.  The individual in this position will design, implement and manage systems for record management and archival to ensure orderly storage and expedient retrieval of all documentation according to GMP/ISO/CLIA requirements.  This is a unique, challenging opportunity to play a leading role in the design and implementation of a document services function at a fast-paced, innovative company.

 

Specific responsibilities include:

 

♦ Developing and establishing Standard Operating Procedures for Company document control

♦ Managing the document control system including the preparation and processing of DCOs, and editing and release of controlled documents

♦ Controlling (to include orderly filing and security) of original Controlled Documents including Standard Operating Procedures, Specifications, Master Batch Records, Design History Files, completed Project Documentation Packets, completed Batch Records and training records

♦ Participating in and assisting with regulatory agency inspections

♦ Developing and delivering company-wide training on relevant procedures and good documentation practices

♦ Participating in the selection, implementation and management of an electronic document control and document management system

 

Qualifications:

♦ Bachelor?s Degree preferred.

♦ At least seven (7) years of Document Control experience including the implementation of Document Control software packages

♦ A minimum of five (5) years of experience in a cGMP/ISO 13485 environment required

♦ Experience in an IVD or medical device company essential

♦ High level of skills with Microsoft Office (Word, Excel, Outlook)

♦ Excellent written and verbal communication skills

♦ Ability to work in cross-functional team settings

 

Compensation

 

To attract highly qualified individuals who excel in their respective fields, Aviir offers employees an attractive compensation package that includes healthcare and dental plans, 401(k) retirement plans, and supplemental insurance.  All employees receive stock options in addition to their base salary.

 

Contact

 

To apply, please email your resume/CV and a cover letter describing your interest and career objectives to jobs@aviir.com , with the above position in the subject line.  PDF and Word formats are preferred, but not required.  Please: no phone calls, walk-ins, or agencies.