This position is one which requires a strong technical background, a high degree of enthusiasm, enjoyment of working in a fast paced environment, being self-motivated, and being able to use critical reasoning to solve problems and make decisions. Updates logs, databases and catalogues. Coordinates the review and revision of procedures, forms and policies. Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness. Assists in compiling audit preparation documents and maintaining computerized files to support all documentation systems.Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Normally receives no instructions on routine work, general instructions and supervision on new assignments.
Work with a document/training management system and author supporting written standard operating procedures to meet organizational needs
Manage an on-site controlled/limited access document archive
Manage processes of off-site commercial document archiving vendor
Process, maintain and control documentation (policies, procedures, forms, reports, manuals, etc.) supporting internal departments and external vendors as required by the current Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and/or Good Manufacturing Practices (GMP) regulations and as required by International Standards
Review documents to determine distribution requirements and process distribution requests according to set procedures
Organize filing systems for hard-copy and electronic documents
Perform data entry for tracking documents and specimens
Provide information, data, reports, meeting packets, and briefings in support of informal and formal meetings and management review
Provide support for maintenance and continuous improvement of Ora’s Quality Management Systems (QMS), including but not limited to Internal/External Audit preparation, processing of documentation for Deviations, Equipment Identification and Calibration records, Vendor Qualifications, Equipment Validations, and Quality Agreements
Provide QA support of Clinical Labeling Operations and shipment of Investigational Product to clinical trial sites
Perform other Quality Assurance related duties as assigned
REQUIRED SKILLS AND ATTRIBUTES:
Must be able to demonstrate through prior work experience familiarity with the clinical trial process.
A minimum of 2-5 years of document control experience working within a regulated environment.
Ability to work well in a team environment, have a strong commitment to the accomplishment of tasks, can follow procedures, and has the initiative to identify opportunities for improvements and the inter-personal skills to promote and accomplish constructive solutions to problems.
Competency in Microsoft Office applications including Excel
Ability to work in a fast-paced environment
Attention to detail with emphasis on accuracy and quality
Ability to prioritize work to balance multiple projects and deadlines
Excellent verbal and written communication skills
Exceptional customer service skills
Experience working with document management/training software applications strongly desired
Experience working with Microsoft applications
Experience creating electronic forms
Experience in other areas of GXP/GCP Quality Assurance