Responsible for maintaining the procedures necessary to ensure Drug Safety
Evaluation (DSE) operates in compliance with quality standards for the
complete document lifecycle from generation to archiving to
disposition. Primary responsibilities include (but not
Document and data archiving to meet regulatory requirements; to ensure the
receipt, inventory, disposition, tracking, and retrieval of DSE and other
Allergan departments' documentation and other forms of raw
data and assets.
Performs day to day maintenance and organization of DSE archive rooms.
Coordinates the transfer of data, assets, and documentation to long term
storage facilities (including maintaining Archive Transfer Records) for in-
house and Allergan-Sponsored studies.
Performs item-specific inventory and indexing of incoming documents, data, and
Issues study and report numbers, and notebooks to personnel.
Maintenance of personnel records including (but not limited to): SOPs and
Administers and provides computer system support to personnel, for systems
used within or by DSE.
Maintenance and facilitation of controlled document review and approval via
Facilitates the formatting, editing, and reviewing of departmental procedures
(i.e., SOPs) for approval by management.
Electronically distributes study protocols and protocol amendments to study
personnel for documentation that they have been read & understand as
Prepares, manages, and maintains associated forms, tracking lists, and
archiving documentation for all of DSE.
* Education equivalent to a MS degree in a scientific field, or
* B.S. degree in Library Science or a scientific field and at least 4-5years experience in a GCP/GLP or quality regulated environment preferably within a pharmaceutical or consumer product research organization preferably with 2 out of 5 years in a QA arena or equivalent transferable experience.
* Good understanding of electronic documentation systems, quality assurance and/or regulatory affairs.
* Working knowledge in records management principles (electronic and paper based) and or certification by Academy of Certified Archivists a plus.
* Skilled use of Windows based systems, advanced word processing principles, databases, spreadsheets, page layout software, and conceptual knowledge of enterprise-wide document systems.
Essential Skills and Abilities
* Computer literacy in Windows platforms, database applications, an electronic records/document management systems.
* Well-developed understanding of GLP principles as they apply to archiving, retention, and documentation.
* Well-developed communication skills, verbal and written.
* Ability to work well with all levels and types of individuals.
In addition to a scientific background, this position requires strong
knowledge of GLP standards and other applicable regulatory
requirements, effective written and oral communication skills are required,
Windows-based platforms with various types of database applications (word
processing, spreadsheet, page layout, styles, etc.) necessary to operate
quality system databases, comfortable working in a computerized environment,
and ability to learn electronic databases and enterprise management software.
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