JOB PURPOSE The Document Control Coordinator will coordinate document control activities related to the document management system and data management. This position is also responsible for interfacing with all departments to organize, maintain and edit documentation in support of our Client's products and quality system processes.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES The following are the essential functions of this position. This position may be responsible for performing additional duties as tasks as needed and assigned.
Coordinate the activities of Document Control, including the tracking, release, distribution and auditing of controlled documents, maintenance of electronic department directories, and tracking and reporting on document review progress. The Coordinator must work independently to facilitate group activities.
Manage archival activities for controlled documents.
Organize and facilitate approval process of Change Control Orders (DCO), and Engineering Change Orders (ECO), including distribution and archiving of final documents whether hard copy or electronic.
Collaborate with subject matter experts on technical subjects in a positive manner to prepare controlled documents which conform to our Client's defined format.
Review and proofread documents for consistency of document format and system concerns.
Use department software to track, manage, and control issued documents. Assign identification numbers as required.
Assign training timely and accurately according to the appropriate training matrix.
Effectively follow SOPs, policies, and FDA Good Manufacturing Practices. Provide support for the Quality Systems and Regulatory departments during internal and external audits and actively participate in department activities.
Trend documentation activities relating to employee training to support compliance requirements.
Support the internal audit program as needed.
Support external audits as needed.
Support the CAPA program as needed.
Perform other duties as assigned.
MINIMUM QUALIFICATIONSThe requirements listed below are representative of the education, knowledge, skill and/or ability required for this position.
High School Diploma or equivalent required
Experience, Skills, Knowledge and/or Abilities:
Minimum 1 to 2 years' experience required or equivalent industry experience
Excellent communication, writing, editing, proofreading, and organizational skills
Outstanding attention to detail
Strong interpersonal skills and ability to work with others in a positive and collaborative manner
The education, knowledge, skills and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above.
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