Job Description

Document and Data Control Coordinator:

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 Companys 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; and
• If 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.

Required Experience

A 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.

Benefits

We offer an excellent benefits package including medical, dental, vision, 401K, disability, life, FSA, vacation, and holidays.

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