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Quality Manager (Newton (MA))


Date: 2009-11-02, 11:23AM EST
Reply to: job-hxv9h-1447901888@craigslist.org [Errors when replying to ads?]


New England Cryogenic Center (NECC) and New England Cord Blood Bank (NECBB) is a biotech company looking to hire a Quality Manager. NECC and NECBB currently processes and cryopreserves multiple types of tissues for later use.

Main Responsibilities
1. Ensure that all quality activities are performed in compliance with company Quality Plan.
2. Report to Executive Management on the effectiveness of the Quality System.
3. Report on a regular basis to Executive Management on the performance of the Quality System.
4. Establish a schedule for performance of quality monitoring, audits and reports as required for maintenance of Quality Systems.
5. Communicate with department heads to ensure that they maintain department specific Quality Systems.
6. Act as liaison for all matters relating to quality activities.
7. Ensure compliance with document control regarding change control of documents including SOPs, forms and archive of documents that effect change control.
8. Resource for FDA compliance related to tissue activities.
9. Perform other related duties as assigned.

Previous experience working within a Quality System setting is required. Familiarity with FDA regulations (specifically 21 CFR 1271) and AABB Standards and experience working in a cGTP or cGMP environment is preferred.

Some travel, domestic and international, will be required.

PostingID: 1447901888