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The Document Control Specialist is responsible for assuring that Quality Records are identified, collected, implemented, revised, indexed, filed, stored, and maintained in a manner, which ensures integrity and accessibility. Provides clerical/administrative support to the Training and Development function. Responsible for the record keeping and training documentation, including the Compliance Wire training and tracking system.
DUTIES and RESPONSIBILITIES
Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate, procedures and guidelines, this
position: The Documentation Specialist 2 is responsible for administering, maintaining, and monitoring the company's document control activities in accordance with
FDA/QSR, ISO 13485 requirements and other international regulations. Responsible for implementing the processes and procedures as outlined in the document management system. Verifies and maintains document files. Ensures revisions to master documents reflect approved changes, as directed.
Updates, reviews, and verifies master indexes and files. Ensures distribution of changed documents. Identifies obsolete documents and ensures their destruction. Ensures filing and maintenance of batch record documentation. Records Coordination of archiving, retrieval, and retention of Quality Records with offsite storage supplier. Administrator of the Training Management Training System and Processes training requests. Responsible for communicating business related issues or opportunities to next management level. Participate in on-site inspections by internal personnel or external/ third party regulatory agencies. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. Verifies records received and procedures adheres to Good Documentation practices. Performs other duties assigned as needed
EXPERIENCE AND EDUCATION
Minimum 3- 6 years' experience and a bachelor's degree, or equivalent is preferred in the medical device industry with demonstrated quality system knowledge including 21 CFR Part 820 (QSR) and ISO 13485
Experience in the Medical Device industry or medical field
Knowledge of specific business practices and software and software applications
Experience maintaining ledgers and other fiscal documents
Ability to work cooperatively with coworkers and the public
Ability to perform duties in accordance with policies and procedures
REQUIRED KNOWLEDGE and SKILLS
Experience in a related field, preferably experience working within a quality management system for a medical device manufacturer, ISO experience is an asset
Document review and procedural writing experience is preferred
Proficient in computer applications such as, Microsoft Word, Excel, Access, Microsoft Share Point and Outlook
Experience of office procedures, including filing, record management and archiving documentation
Experience with Document Management and LMS tools such as Adaptiv and Compliance Wire a plus.
High attention to detail and ability to solve problems and communicate issues; ability to work on multiple projects simultaneously.
Strong communication and organizational skills.
Ability to work autonomously or in a team environment.
RESPONSIBILITY FOR OTHERS and INTERNAL INTERACTIONS
Acting as the main office support for the department
Works with other department such as Manufacturing, Purchasing, Engineering to ensure Change management and records are retained and processed per procedure.
Support Internal Audits.
PHYSICAL WORKING CONDITIONS and REQUIREMENTS
Must be able to complete repetitive movements for extensive periods of time.
Must be able to sit for longer periods of time.
Must be able to file and store documents in boxes.
LOCATION and TRAVEL REQUIREMENTS
No travel required.
Support and represent department during External Audits
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