US-MA-Cambridge: enior QA Specialist

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Date: 24-Feb-2009

enior QA Specialist Description:

We are seeking a highly motivated and creative Quality professional with in depth experience with Quality Systems, Document Management and Training. Prior experience with electronic document systems preferred.

Duties and Responsibilities:

* Assist in initiating and maintaining change processes for new documents and document revisions. * Responsible for control and security of all official documents (SOPs, Cs of A, Batch Records, Internal and External Reports etc.) and their storage in the high density document room. * Responsible for copying, distributing, filing and tracking batch records, vendor files, audits etc. in the QA files. * Assist in maintaining training records and ensure training is complete and properly filed. Ensure training is performed within appropriate time frames. Prepare training documentation and perform training where applicable. * Support development and maintenance of Quality Systems. * Represent Quality Assurance within project teams identifying and providing input on quality issues. * Assist in performing batch record reviews. * Other similar duties as assigned by supervisor.

Job Requirements:

Experiences Desired:

* 5 years Quality Assurance experience in a Pharmaceutical/Biotech setting * Proficient Computer Skills including MS office products – experience working with and/or implementing an electronic document and Quality System management application (e.g. Pilgrim, Track Wise etc.) a strong plus * Excellent written, verbal and organizational skills * Must be detail oriented and have strong prioritization skills * Ability to handle multiple projects and bring them to completion in a timely manner * Ability to work independently and also in a team environment

To apply for this position, please visit this Website.

Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/