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MGS Mfg. Group

Document and Data Control Coordinator - Richfield

MGS Mfg. Group, Richfield, Wisconsin, United States, 53076


Job DescriptionMGS has an exciting opportunity for a Document and Data Control Coordinator to join our MGS Richfield team. We have an 8 hour day shift opening.The Document and Data Control Coordinator is responsible for properly maintaining internal library procedures to ensure appropriate personnel access occurs and storage of official documentation is maintained at the MGS Richfield manufacturing facility.Below are additional duties and responsibilities:Learn and master all necessary areas of the quality system.Follow Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).Responsible for the Company's Quality System, Product, Electronic, and Hard Copy document libraries.Coordinates with all departments of the Company in order to assure that all documents are stored in the correct place and that document and data control procedures are consistently followed.Ensures that all documents are submitted on time and reviewed for adequacy and approved by designated personnel prior to issuance or distribution.Ensures the timely review, distribution and implementation of all customer engineering standards/specifications and changes based on customer-required schedule.Maintains records of the date on which each change is implemented.Provides for documents and data availability.Maintains records of changes to documents and data.Confers with document originators or engineering liaison personnel to resolve discrepancies and compiles required changes to documents.Posts changes to computerized or manual control records, releases documents, and notifies affected departments.Ensures that all obsolete documents are promptly removed from all points of use or otherwise prevented from unintended use.Compiles and maintains control records and related files to release blueprints, drawings, and engineering documents to manufacturing and other operating departments.Develops and controls Device Master Records which include:Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;Packaging and labeling specifications, including methods and processes used; andIf necessary, installation, maintenance, and servicing procedures and methods.Ensures that all records required by the Company are maintained and that they are reasonably accessible to responsible officials of the manufacturer.Ensures that records remain legible and are stored to minimize deterioration and to prevent loss.Maintains and controls the record retention schedule for the Company.Develops and controls Device History Records which include:Establish and maintains records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record.Any other duties as assigned.About MGSAs a global provider of healthcare manufacturing solutions, MGS provides the right balance to drive vital innovations: robust end-to-end solutions combined with the strong customer focus and seamless collaboration of an agile partner. That's why we're the engineering and manufacturing partner of choice for today's leading Pharma, Diagnostic and MedTech innovators. Serving customers from 12 strategically located facilities around the world, we transform our customers' most pressing challenges into innovations that improve lives. To learn more about MGS, please visit www.mgsmfg.com.Experience and SkillsA qualified Document and Data Control Coordinator would fulfill these requirements:High school diploma or equivalent is required. Completion of an accredited two-year technical college program, or a four-year university program, in a related field of study is preferred.Previous experience working in a project or technical environment.Computer literacy is necessary.Strong organizational skills.Job BenefitsWe offer an excellent benefits package including medical, dental, vision, 401K, disability, life, FSA, vacation, and holidays.