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Job Information
Job title

Documentation Specialist (#8185528)

Company Sai People Solutions, Inc.
Wage Not specified
Location United States, California, Oceanside
Employment type Full Time
Education High School
Year Experience 4 - 5 Years of Practical Experience
Travel Not Specified
Published on 3/31/2006
Description
DUTIES >> General Summary Execute and maintain the tasks and responsibilities of the QA Documentation Department. Provide documentation support to the departments requiring controlled documentation. Principal Duties and Responsibilities A. Essential Functions . Maintain databases used in tracing documentation routing, history and reporting. . Formatting, typing and editing of QA Controlled documents . Perform document revision and assist in the approval process . Provide metrics for completed function when requested . Monitor and maintain the Documentation reports as needed . Coordinate Binder Location Audits with GMP areas. B. Additional Functions . Observe for non-compliance of GMP throughout all applicable areas and functions and ensure compliance when observed. . Create or update all functionally relevant controlled documents as needed . Provide required documentation to Regulatory Affairs for FDA submission filing . Perform related work as required Job Demands . Demonstrate excellent proof reading and grammatical skills, and good attention to detail. . Demonstrate ability to facilitate multiple tasks . General supervision is required . Able to handle a moderate degree of stress, changes in priorities and frequent interruptions . Demonstrate strong interpersonal and communication skills both verbally and written . Able to maintain knowledge of cGMPs, which may involve attending training sessions . Demonstrate a high degree of confidentiality / professionalism and work well with personnel as all levels of skill and authority throughout the company. Job Impact . If duties are not performed in an error-free, timely, and well documented manner, filing of a FDA submission and receipt of outside funding my be delayed. . If documentation is not maintained on a daily, diligent basis, company's compliance reputation may suffer. SKILLS >> Qualifications A Essential . High school degree or GED . 1-3 yrs experience maintaining documentation system . Intermediate ability with various computer systems and experience using Microsoft Word and other software packages. . Electronic Document Management System (EDMS) experience a plus . Strong communication, organizational and coordination skills . Excellent proof reading and grammatical skills and good attention to detail . Ability to manage multiple tasks B Preferred . 1-3 yrs experience with Document Control Systems in a biotech or pharmaceutical company. . Knowledge and overall understanding of biopharmaceutical manufacturing and manufacturing support processes . Working knowledge of FDA Requirements for GMP compliance . Commitment to quality and pride in work


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Experience/Skills
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Other desired skills:
Documentation Specialist (#8185528)
This job has expired.