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| | | Job Title: | Technical Writer (GxP, GLP, GMP) | | Job Category: | Info Technology | | Job description: | ? | | Job Description: Responsible for authoring manually executed process steps. Understands validation concepts in order to produce documentation for validated systems following regulatory requirements. Applicant must have excellent written and oral communication skills in order to explain complex ideas and tasks to users. Capable of performing effectively in a team, or alone and unsupervised. Communicates effectively with team members and management. Experience in authoring documents as part of a structured software development life cycle or manufacturing, processing, testing, holding and distribution of pharmaceutical or biological products. Desired Skills: MS Word o MS Excel o MS Outlook. Documentum. Sharepoint Business Skills & Knowledge. Knowledge of Software Development Lifecycle (required). Pharmaceutical Industry Experience (preferred) Knowledge of GxP (GLP, GMP, or GCP) and 21 CFR Part 11 Regulations (preferred). Excellent verbal & written communication skills. Pharmaceutical or Vaccine Manufacturing experience Preferred. MUST HAVE AT LEAST 2 YEARS RELATED EXPERIENCE. MOST CRITICAL SKILLS: DOCUMENTATION EXPERIENCE; GXP (GLP, GCP, GMP) DOCUMENTATION EXPERIENCE Skills Importance Experience Competency Documentum Desired 1-3 years Advanced MS Excel Required 1-3 years Advanced MS Office Desired 1-3 years Advanced MS Outlook Desired 1-3 years Advanced MS Word Required 1-3 years Advanced Sharepoint Desired 1-3 years Advanced 21CFR Part11 Desired 1-3 years Advanced Good Lab Practice (GLP) Desired 1-3 years Advanced Good Manufacturing Process (GMP) Desired 1-3 years Advanced Regulatory Documentation Desired 1-3 years Advanced Pharmaceutical Manufacturing Desired 1-3 years Advanced | | Skills: | ? | | | | Employment type: | | | Salary Range: | Unspecified | | Job Link: | You must first register to view this information. | | ? | | | | ? | | Degree: | | | Experience (year): | 0 | | Job Location: | Charles City - Iowa - USA | | Zipcode: | 50616 | | ? | | Post Date: | 04/09/2012 | | ? | | | | ? | | Contact Name: | GDI Infotech | | ? |  | | ?
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04/04/2012 GDI Infotech Charles City - IA - US 04/09/2012 RCM Technologies Charles City - IA - US 03/27/2012 NewageSys, Inc Array - IA - US 04/04/2012 Array Charles City - IA - US 04/05/2012 Kelly Scientific Resources Charles City - IA - US |
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