DescriptionResponsible 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 limited to):
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 specimens.
Issues study and report numbers, and notebooks to personnel.
Maintenance of personnel records including (but not limited to): SOPs and training records.
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 electronic processes.
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 requested.
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.
- 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.
Last updated: Tuesday, February 28, 2017 23:45 UTC