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WHAT
IN
Technical Document Specialist
Job
Talecris Biotherapeutics
US
-
Clayton,
North Carolina
Job Code - 4166
Position - Full - Time Regular
Job First Active on: Thursday, November 05, 2009
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JOB DESCRIPTION: Technical Document Specialist
The Technical Document Specialist’s role for the Filling/Packing Business Unit (BU) is to support the areas of documentation review, document revisions, incidents, and projects. Detailed responsibilities include:
Documentation Review – Review and sign-off of BPRs, ensuring proper error corrections, categorize and track errors, maintain logbooks, and conduct training on reducing errors
Document Revisions – Revise and author BPRs and SOPs, track documents, gather supporting information for revising documents (i.e. validation documentation), ensure compliance based on regulatory and licensing requirements, consult with SMEs to ensure execution flow and consistency, and provide clarification for documents training
Incidents – Write cause investigations, gather supporting documentation product impact assessments, recommend product dispositions, create CAPAs, conduct CAPA effectiveness reviews, execute Trackwise entries, categorize and track incidents, and maintain KPIs
Projects – Independently lead projects, create and execute ETPs, create and track CCRs, assist with trouble shooting/problem solving complex equipment/process issues, and provide trending assessments
This position requires rotational assignments between each role. Initial assignment to a specific role will be based on the candidates strengths and BU needs.
REQUIREMENTS - QUALIFICATIONS: Technical Document Specialist
For an M06-BS and 4+ years of experience; MS degree and 0-2 yrs; PhD and 0-2 yrs; for an M08- BS and 6+ years of experience; MS degree and 0-4 yrs. Expertise is required in 2-4 unit operations and 1-2 functions or departments.; PhD and 0-2 yrs or an equivalent combination of education and experience. A proactive philosophy, attention to detail, ability to work independently, and strong interpersonal skills are essential and must have been demonstrated in previous work. In addition proven computer skills with demonstrated proficiency in Microsoft Word, Excel, and Access is required. Incumbent must be able to independently recognize trends, monitor cycle times, develop and implement solutions, prepare reports/presentations and be able to effectively communicate with varying levels of management. Incumbent must possess excellent written, verbal communication skills. A working knowledge of site systems and databases such as SAP/BIOMAN/LIMS is desired.
No agency calls please. Talecris offers a competitive salary and benefit package including 401(k) with company match, performance bonus and profit sharing. Recently voted to the Companies That Care, Talecris is proud of its work, life, balance programs and its generous tuition reimbursement program. We have the expertise, resources and established business infrastructure to develop, manufacture and market biotechnology products internationally. An Equal Opportunity Employer M/F/DV, Talecris Biotherapeutics is committed to enhancing and manufacturing cultural diversity within our work environment.
Talecris Biotherapeutics
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