Adecco Engineering and Technical is currently recruiting for a contract Document Control/Records Management job located in Irvine, CA.
Candidate must have Archive/GLP experience.
The pay rate for this position is up to $25/hr.
Responsible for maintaining the procedures necessary to ensure Company 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 documentation and other forms of raw data and assets.
Performs day to day maintenance and organization of 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.
Maintenance and facilitation of controlled document review and approval via electronic processes.
Prepares, manages, and maintains associated forms, tracking lists, and archiving documentation
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. The individual must operate with minimal supervision.
KEY DUTIES AND RESPONSIBILITIES:
Archive: Fulfills the requirements of an Archivist as defined in the GLPs (21 CFR Part 58), including:
Managing & overseeing the preservation of the hardcopy and digital information assets, specimens, and samples of GLP and non-GLP study raw data, protocols, reports, equipment logs, and electronic records
Maintenance of detailed records and control of documents transferred to and from long-term storage facilities.
Accessioning of records to ensure materials are recorded and indexed for archiving.
Maintaining and organizing archive rooms and filing of documents, specimens and samples.
Assists in the retrieval of physical and digital information assets needed for scientific and regulatory purposes.
Liaison to CROs for archival of Company sponsored studies. Evaluates needs for documentation return or storage at long-term storage facilities. Facilitates document transfer between facilities.
Collaborate with corporate archiving group on corporate initiatives. Ensures requirements are addressed by the processes or systems, and disseminates initiative information to management and personnel.
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.
If you are interested in this Document Control/Record Management Position, CA then please click APPLY NOW. For other opportunities available at Adecco Engineering and Technical go to www.adeccousa.com. If you have questions about the position please contact Natalie Handal at 858-812-9813 or firstname.lastname@example.org today!
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