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Subject: JOB POSTING: US-CA-Fremont-EDMS ( Electronic Document Management Specialist)
From: Peter Kurilecz <[log in to unmask]>
Reply-To:Records Management Program <[log in to unmask]>
Date:Sun, 8 Dec 2002 12:43:28 EST

text/plain (79 lines)

The following was found on -- Peterk

Protein Design Labs, Inc. (PDL) is a leading developer of humanized 
monoclonal antibodies to prevent or treat various disease conditions. PDL 
currently has antibodies in clinical development for autoimmune and 
inflammatory conditions, asthma and cancer. PDL provides a collaborative team 
environment where we encourage you to use your creativity, seize individual 
responsibility, and take initiative to go beyond the challenges of your job. 
We are looking for talented, motivated individuals to contribute to our 
vision and join the PDL team at our Fremont, California location.
This position will be responsible for providing a lead role in the activities 
of the Document Management Group. These activities are installation, 
implementation, maintenance, documentation of the systems, validation, 
enhancement of the systems, and conformance to GMP and FDA 21 CFR Part 11 
regulations as it pertains to Information Systems. This position reports to 
the Manager, IS. Principle duties and responsibilities include: monitoring 
the process of maintenance and archiving of all internal documents and 
documentation, including drafts, originals and subsequent versions of 
contracts, proposals, modifications, general communication, agreements, 
technical documents, white papers, policies & procedures, guidelines, 
agendas, plans and programs meeting minutes; coordinating the above 
documentation into a company-wide document management system; assisting PDL 
in selecting, implementing, and maintaining customer required DMS solutions; 
tracking and coordinating all incoming and outgoing customer documents for 
all document scanning, conversion & management projects in the production 
services at all locations of PDL and any deployment sites, domestically and 
internationally; traveling between sites as needed; maintaining the DMS 
software and being primarily responsible for maintaining the DMS, organizing 
folders, files and security; installing, implementing and acting as project 
manager of EDMS projects; writing and implementing policies and procedures 
concerning: versioning, check-in, checkout, data security, archiving and 
records retention requirements; creating and conducting periodic internal 
audits of internal and customer documentation; acting as a “subject-matter 
expert” on document management to advise on projects during needs assessment 
process with product planning and then in the quality assurance process, 
namely verification of the completeness of deliverables; providing leadership 
to the EDMS staff members in the group; assisting the Manager, IS in creating 
and maintaining a documented, clear and concise Electronic Document 
Management architecture; obtaining a thorough knowledge of company practices 
and procedures; implementing DMS solutions in accordance with CGMP practices 
and FDA 21 CFR Part 11 regulations as it pertains to Information Systems and 
performing other projects as assigned. Candidates must have a BA/BS in 
computer science, related field, or equivalent experience with 3-8 years 
experience in Document/Records Management and Document Management Systems 
(i.e. Documentum, Qumas, PCDocs, Lotus Domino Docs, Opentext.). Additional 
requirements include: expert manual and electronic organizational skills, 
logical skills and attention to detail, knowledge of ISO-9000 or 9001 
Document Management Standards, including document numbering systems and 
document distribution, knowledge of CGMP and FDA 21 CFR Part 11 regulations 
as it pertains to Information Systems, knowledge of requirements for 
versioning, security and records retention (i.e. original contracts, 
accounting information, HR information, legal documents, pharmaceutical 
manufacturing documents etc.) and strong computer skills including Windows 
2000 (Pro and Server) and MS Office, Adobe Acrobat or similar. This 
individual must have excellent/proven oral and written communication skills; 
excellent/proven knowledge of MS SQL or Oracle database software, 2 – 4 years 
experience with Visual Basic and/or Visual Basic scripting languages, 3 – 6 
years experience with image capture technology preferred, excellent 
interpersonal skills and ability to effectively respond to all customer 
inquires and complaints. This position requires the ability to: travel 
domestically (if required) – average 5% of the time, to learn and apply 
organizational policies, laws, rules and regulations and to work on complex 
problems where analysis of situations or data requires an in-depth evaluation 
of various factors. This individual must exercise judgment within broadly 
defined practices and policies in selecting methods, techniques and 
evaluation criteria for obtaining results. This candidate must get along with 
coworkers, work under supervision and have good attendance.

Additional Information  
Position Type: Full Time, Employee 
Ref Code: 1250- MZ  
Contact Information 
<A HREF="mailto:[log in to unmask](%20Electronic%20Document%20Management%20Specialist)%20-%20II%2FIII%20(1250-%20MZ)">[log in to unmask]</A>
Protein Design Labs     

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