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Job: Archivist (Amgen: Thousand Oaks, California) 

Forwarded to STHC-L from ARCHIVES. Apologies for the delay -- wading through 
the chaff on ARCHIVES is a bit of a task (that takes a strong finger on the 
"Delete" key). --RJ

----- Original Message -----
From: Peter Kurilecz [PAKURILECZ@AOL.COM]
Date: Thursday, December 4, 2003 6:06 am
Subject: Job Posting: California

the following comes from a colleague of mine in the Golden State and 
thought some folks here on this list might be interested. Contact 
information is at the bottom of this message

peterk


As the largest biotechnology company on the planet, Amgen offers 
the chance to truly innovate and contribute to the big picture in 
science. Our R&D focus on nephrology, oncology, inflammation and bone 
disease, and neurology has already produced six marketed products with 
a promising pipeline of new human therapeutics to come. A world-class 
sales force, global manufacturing operations, and clinical development 
sites on three continents complete our picture as a Fortune 500 company 
and a leading biotechnology company committed to improving people's 
lives. And Amgen continues to grow with our successes. We currently 
have the following opportunity at our Thousand Oaks, CA facility.
PCD Archivist II
Requirements:
Education/Licenses- 
Bachelor's degree or the equivalent combination of education and experience. 

Experience-
Typically 2-6 years experience in a records center. Proven knowledge of 
document management systems, inventory systems, spreadsheets and word 
processing software. Strong understanding of applicable international 
pharmaceutical regulations, guidelines, and procedures as they pertain 
to GLP study material archiving (preferred). 

Competencies/Skills- 
Strong communication skills (both written and oral). Strong computer 
operation skills. Strong interpersonal skills. Ability to anticipate, 
communicate, and resolve problems. Organizational skills necessary for 
indexing, cataloguing and referencing archived material. Demonstrates 
ability to lead teams in a matrixed environment. 
Job Summary:
The Preclinical Development Archivist (Archivist) is responsible 
for maintaining the storage of paper and electronic records, raw data, 
specimens, samples and other GLP study materials (collectively 
'Material') as required by 21 CFR Part 58 for Preclinical Development 
(PCD). In addition, the Archivist will be responsible for the development 
and continuous improvement of the operation of the PCD Archive, which is 
required to meet the GLP regulations for the archival of Toxicology, 
Pharmacokinetics & Drug Metabolism, Clinical Immunology, and Pharmaceutics 
Material. The Archivist will sponsor and participate in the development 
and implementation of IT solutions, which will improve the accurate and 
expedient retrieval of Material from the Archive. The Archivist will 
represent the opinion of PCD Management on company wide initiates 
related to records retention, electronic raw data storage, etc. The 
Archivist will contribute forward thinking solutions, required to continuously 
improve the PCD archiving and materials management challenges, as well 
as conduct the daily operational tasks, necessary to maintain all 
phases of the Archive. 


FUNCTIONS (Duties/Accountabilities) 

1. Collaborates with the PCD Department Heads and external stakeholders 
to develop and continuously improve the PCD Archive's Standard 
Operating Procedures. 

2. Maintains the PCD Archive's inventory of Materials by tracking and 
accounting for the Material as it moves from the PCD Departments to 
and within the on-site PCD Archive, as well as to (and possibly from) 
a long term off site storage facility. 

3. Develops Quality Control measures within the Archive, to ensure 
integrity of information maintained within the Archive's electronic 
tracking tool, which will allow accurate and quick retrieval of 
archived Materials. 

4. Proposes budgets, resource requirements, workflow procedures, in-house 
training courses, and Archive related project timelines for the PCD Archive. 

5. Sponsors Archive IT systems solutions, which shall include input on 
the design, system testing, validation, implementation, and user training. 

6. Follows international regulations and guidance documents relating to 
records management and retention periods. Develops policies and procedures 
in compliance with Amgen's interpretations of said regulations. 

7. Acts as the Archive representative for internal and external audits 
of the GLP Archive, to ensure regulatory, ICH, and GLP compliance. 

8. Develops and reviews contracts with external vendors and consulting 
organizations, involved in the development, maintenance, and archival 
of GLP study Material. 

9. Represents Preclinical Development on archive, record retention, 
electronic records, etc. company wide initiatives addressing industry 
standards, guidelines and archival technology. 

10. Interacts with and guides the PCD Department Archive Representatives 
in development of, ongoing enhancement of, and compliance with PCD 
Archive SOPs. 

11. Appraises and maintains the Archive and the working environment within 
the Archive in a healthy and safe manner, in accordance with company 
policies and OSHA requirements. 

Amgen’s outstanding compensation package features comprehensive benefits 
and relocation assistance. Come be a part of the big picture at Amgen. 
Interested candidates email resume to smaguire@amgen.com. Job ID: 
amge-00004554. 


Peter A. Kurilecz CRM, CA
Richmond, Va
pakurilecz@aol.com
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