QUALITY ASSOCIATE III

The responsibility of the position is to support quality systems site wide for Engineering/Utilities. The  main responsibilities are to assist with ITS coordination, change control coordination, support of the utility business unit, and review of weekly Utility packets/other utility documentation. Responsibilities for ITS include QO classification, assistance with investigations to determine causes/appropriate CAPA, control of product batches, assistance with/authoring of product impact assessments, review, completion of ITS templates, and preparation of packets for closure. The ITS role also includes attendance of ITS consistency meetings, training of Trackwise users, and reporting of utility ITS metrics for QO utility/computer system management. The position assists with change control coordination in support of routine and building shutdown changes. Responsibilities include review and completion of packets for weekly utility and lab utility data, and filing in Extempore/central records. These packets include trends for temperature, TOC, conductivity or dewpoint on the WFI, Pure Steam and Compressed Air systems, as well as  WFI system breach paperwork, WFI system sanitizations, quarterly plant steam, and chemistry data.  Other responsibilities of the position consist of assistance in implementation of the Site Validation Master Program, validation review, SOP review, new instrument/PM sheet review, participation in continuous improvement initiatives, and other assignments as requested by management. This position requires a PhD in Life Sciences with minimal experience, MS in Life Sciences with a minimum of 2 years relevant experience or a BS in Life Sciences with a minimum of 4 years relevant experience at the M06 level.  The M08 level requires a PhD in Life Sciences with 2 years of relevant experience, MS in Life Sciences with a minimum of 4 years relevant experience or a BS in Life Sciences with a minimum of 6 years relevant experience. Interested persons may apply online at: www.talecris.com to Req. #1189. No online applications, agencies or phone calls please. Talecris Biotherapeutics offers a competitive compensation & benefits package including immediate 401(k) vesting and profit sharing. Relocation available for the right candidate who brings high energy and top talent to the position. All benefits take effect day one of employment. Talecris is proud of its work/life/balance initiatives & its generous tuition reimbursement program. We have the expertise, resources & established business infrastructure to develop, manufacture & market biotechnology products internationally. An Equal Opportunity Employer M/F/D/V, Talecris Biotherapeutics is committed to enhancing & maintaining cultural diversity within our work environment.