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Position: Documentation Coordinator
Prepares submissions of SOPs for the document control process controlled through QUMAS, ensuring compliance to ISO, GMP and BSI regulations, utilizing the computer networks to prepare documents to the on-line system. This position is responsible for maintaining and supporting departmental internal database maintenance of on-line indices and approved artwork file management and requires auditing of files to ensure artwork accuracy. Lead responsibilities for document triage and process audits for the department. Researches, recommends and implements efficiency improving tools and procedures and takes action/responsibility for developing databases, reports, etc.) Evaluates Workflow Coordinator processes and communicates non-conformances to management. May perform other document-related duties outside the department such as document coordination, customer issue investigation, safety training/inspections, and internal audit support activities.
All systems and procedures will be maintained by meeting ISO/GMP requirements.
Promotes a culture of Regulatory Compliance and Risk Management throughout the organization. Supports departmental and franchise objectives, while adhering to the Pharmaceutical Credo, as well as local safety and environmental policy and procedures
ESSENTIAL FUNCTIONS / RESPONSIBILITIES
1. Edits and prepares new/revised documents and forms that are submitted for the documentation processes, ensuring their compliance to ISO, GMP and BSI regulations (25%)
2. Utilizes computer networks to transfer approved (and effective) documents to the on-line system; maintains and supports on-line indices, organization charts, and signatory matrices (25%)
3. Performs regular audits of documents in approval cycles (10%)
4. Evaluates Workflow coordinator processes and communicates non-conformances to management and affected departments (5%)
5. Identifies group productivity/communication barriers and proposes solutions (5%)
6. May perform other documentation-related duties within the department including customer investigations and training personnel (15%)
7. Performs duties related to Qumas Administrator such as password resets/on-line support (5%)
8. Performs QUMAS training to company-wide individuals (5%)
9. Ireland and Japan point of contact for troubleshooting processes (5%)
III. Minimum education required for competent performance:
Two years technical training education or equivalent experience: high school degree or equivalent required.
Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance:
5 or more years previous clerical/technical experience in document management.
Must have thorough knowledge and understanding of administrative principles and concepts of training others within all applications of the QUMAS environment (eDocCompliance).
Ability to utilize the Global360 database system for retrieving archived documents that are not listed within QUMAS.
Ability to use computer systems for off-site document storage activities.
Proven self-starting/high initiative track record.
Ability to work in a team setting.
Excellent communication skills (both verbal and written).
Knowledge of ISO/GMP/BSI regulations.
Ability to be flexible and work under pressure.
Strong, proven organizational skills.
Ability to handle multiple priorities successfully.
Ability to coordinate and work with multiple departments and cultures.
IV. Volume or unit measure of job duties: (List the volume of those duties, which are repetitive in nature.
Up to 200 documents/forms/investigations/analyses per month
V. Equipment usage and abilities needed:
Personal Computer, Printer, Telephone, Facsimile, Copier, Calculator, Microsoft Office products, Software as required
If "Other ", please specify:
Expertise in company document management computerized system (QUMAS) both administrative side eDocCompliance, Word, Excel, Visio software applications.
Daily interaction with internal/external customers.
Internet/Iron Mountain for processing and retrieving records from off-site storage.
VI. Conditions & Physical Demands of Job
Walking, Hearing, Talking, Standing, Fingering, Repetitive Motions, Inside Environmental Conditions, Sedentary Work
SUPERVISION / AUTHORITY
VII. Indicate below by placing an X next to the level of responsibility, if any, for directing the work production of others. This level of responsibility must be a reflection of the job itself, not the specific incumbent:
Responsible for workflow production, training of new employees on covered jobs, answering job-related questions in one or more areas.
VIII. SUPERVISOR COMMENTARY: It is important that you review each position description thoroughly. Please indicate below by placing an X by the paragraph which most closely reflects the degree to which supervisory control is exercised over the performance of the job:
Under general supervision, works within established guidelines and has flexibility as to method, priority and timing of job duties. Requires moderate amount of initiative and judgment.
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