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Apex Systems Documentation Coordinator in Eden Prairie, Minnesota

Description Apex Systems is currently seeking a Documentation Coordinator for one of our top Medical Manufacturer clients in Eden Prairie, MN Please see below for details about this exciting growth opportunity, and email Lisa at linman@apexsystems.com asap to learn more! Role: Documentation Coordinator Location: Eden Prairie, MN Length: 6 months contract to hire Compensation: $52,000 - $58,000 range depending on experience, qualifications, certifications, etc. Documentation Coordinator AREAS OF RESPONSIBILITY Assist the Director of Regulatory Affairs / Quality Assurance in the updating and modification of the documentation system. Establish priority for routing and approval time frames for each type of document Maintain secure and orderly documentation area. Assist in training support and cross-departmental staff in functional performance of documentation manual policies/procedures. Maintain compliance of the documentation manual policies/procedures. Manage record retention, retrieval and destruction activities. Create batch records for Production for the manufacturing of regulated products. Maintain all Product Master and History Records. Design drawings Logs Employee training Validation and protocols/reports Specifications Forms Standards Product History (documents) Manufacturing procedures Audit reports QC/QA procedures Regulatory documents Batch records Preventive Maintenance Document Review Product Complaint records Maintain an organized filing system for quality system documents and records. File completed batch records, receiving specification, validation protocols / reports, etc Update document file and distribution of documents for daily use by multiple departments Update document / record archive Coordinate all change orders and deviations, assuring timely review. Review for consistent and adequate cross document referencing; assure that all affected documents are addressed and included Maintain a log of all change orders including tracking of general time frame for completion. Schedule, coordinate and conduct periodic and timely open change order review meetings or other remediation efforts as needed to facilitate the completion of the change orders Word processing clean-up of red line changes Backup for quality assurance inspection and performing other related documentation duties. Perform raw material and in process product inspection Assist in distribution of finished product release transfers (1880 s) Develop and maintain databases for quality system data collection and reporting. Performs other duties as apparent or assigned by supervisor. Provide administrative assistant support as needed. Sort and distribute mail Word processing Filing Coordinate orders for QA / Production offsite printing or other documentation needs KNOWLEDGE AND SKILLS REQUIRED High School diploma or equivalent at minimum 2-5 years of work experience with documentation / records organization Fluent ability with computer software (Microsoft Word, Excel, Access, etc.) Excellent organizational skills Ability to work independently and to adapt to changing priorities and anticipate needs Attention to detail and customer service orientated Prior administrative assistant experience a plus Documentation experience in an FDA / ISO environment a plus Knowledge/understanding of cGMP & ISO 13485 or working in a regulated environment a plus Please email Lisa at linman@apexsystems.com if you or anyone you know is interested in learning more about this Documentation Coordinator opening or exciting other job opportunities!! EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status

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