Amylin Pharmaceuticals is committed to improving the lives of people
with diabetes and other metabolic diseases through the discovery,
development, and commercialization of innovative, cost-effective
medicines. Our rapid growth has created the following outstanding
opportunity in San Diego, CA:

 <<Picture (Metafile)>> Job Title:  Document Control Manager
Department:  Quality
Reference #:  AMLN-03274
Job Type:  Regular F/T
RESPONSIBILITIES:

Reporting to the Associate Director, QADC, this position will manage the
Quality Records group responsible for processing, storage, and archival
of GMP and Quality Systems Records (including Batch Records, Analytical
and Stability Data, COAs, Deviations, Change Controls, and CSP
documents). Ensure the accurate processing, filing, storage, and
retention of paper and electronic records according to established
internal procedures and records retention policies. Working with Quality
functional teams and impacted departments, develop and make improvements
to Quality Records work processes, ensuring records management
procedures and work instructions are current. Ensure appropriate
LiveLink folders and related permissions are established and maintained.
Manage the Validation Document Control system. Provide mentoring and
guidance to direct reports and use appropriate methods and a flexible
leadership style to help build a cohesive team and facilitate the
completion of team goals. Assist in the coordination and compliance with
requests of regulatory authorities during internal inspections and
during inspections of contract service providers. Track and trend
records-related metrics. Coordinate and prioritize direct report tasks
and projects.

REQUIREMENTS:

Bachelor's degree required, with at least eight (8) years experience in
the pharmaceutical industry with a minimum of five (5) years direct
experience developing, implementing, and managing documentation or
records systems. Experience with EDMS systems. Knowledgeable in FDA
expectations is essential. Managerial experience is required. Necessary
characteristics include: being a self-starter, goal-oriented, attention
to detail, team-oriented, and ability to multi-task.

Amylin offers competitive compensation, benefits and stock options.
Amylin maintains a drug- and alcohol-free workplace and all offers of
employment are contingent upon satisfactory completion of a
pre-employment drug and alcohol test. Please apply online.
http://www.amylin.com/careers/

AA/EEO Employer.



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