What are the responsibilities and job description for the Document Specialist position at LanceSoft?
Description
Mainly they would be working in Agile Project Lifecycle management program on documents.
Programs : Excel Skills are important. Microsoft Word skills (especially formatting). If possible, Agile or another Product Lifecycle Management Program.
Searching and good investigative skills (like getting to the bottom of why and when a previous change was added or removed).
Excellent attention to detail is a must. Someone who is familiar with Change Control related to documents. Patience in learning and not trying to do it all right away without taking the time to fully understand the processes. Able to organize and prioritize tasks. Maintain logs as needed, up to date and organized.
Job Family Description
Updates logs, databases and catalogues in support of the quality system, guidelines and processes. Coordinates the review and revision of procedures, specifications and forms, such as quality manuals and standard operating procedures. Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness.
Coordinates the compilation and maintenance of regulatory filing documents and maintaining computerized files to support all documentation systems, including archiving documentation according to regulatory requirements.
May maintain documentation such as good manufacturing practices (GMP), good laboratory practices (GLP), and good clinical practices (GCP) procedure manuals and change authorizations in accordance with company policies and government regulations.
May provide training on quality documentation tracking systems and processes.
Job Level Description
Gaining deeper understanding of technical knowledge in area of responsibility.
May operate specialized machinery, equipment or tooling.
Working knowledge of company policies, practices, and procedures.
Receives general instructions on routine work, detailed instructions for new / more complex assignments.
ssignments are moderately complex and require planning and decision-making.
Make recommendations for process improvements or deviations.
Choosing appropriate tasks, sequence, and methods to complete work.
Coordinates information and activities within team as needed.
May coordinate work with third parties, vendors, or customers.
May we deliver training or presentations within group as needed.
Minimum Education / Experience
May require some higher education or specialized training / certification, or equivalent combination of education and experience.
Typically, 1-3 years of relevant experience for entry to this level.
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