Document Control Coordinator
Date de libération
11. janv. 2019
Lieu de travail
Andover - États-Unis
Niveau de carrière
Professionnels (expérimentés, spécialistes)
Qui sommes-nous ?
Straumann partners with passionate people who fit in with the agile dynamics of our size-for-success company. People at Straumann appreciate the opportunity to shape the future and create impact. Encouraging leadership and inspiring ideas from our people have guided us through our proud history of pioneering innovations.
- Position Summary:
- Update and enter documentation into an electronic database (GDM or PLM) designed for document control.
- Maintain files/ records (hard copy and electronic) in relation to document revisions, distribution and change information.
- Follow and review submitted documentation for conformance to documentation requirements specified in SOPs, such as approval requirements.
- Distribute controlled copies of documentation to departments/ personnel.
- Send documentation distribution / change notification to personnel, including training requirements as specified in company training matrix/ documentation.
- Enter data from training records in to training database, and run training summary reports monthly.
- Drafts Forms, Process Work Instructions, and SOPs
- Assists with internal training on SOPs, Work Instructions, and other quality documents
This position maintains training records and quality databases, follows up with department managers to ensure training is performed, and runs monthly employee training status reports required under the Company’s Quality Management System.
Major Responsibilities of the Position:
- Minimum Qualifications:
- Detailed knowledge of Quality System Regulation and/or ISO requirements for Control of Documents. (GMP/ ISO/ QSR/ FDA)
- Understanding of document flow process in a regulated industry
- Knowledge/ comfort with the use of computers for collecting, entering and logging data and for various data bases.
- Must be highly organized; maintain files, control of multiple files, documents and records during processing.
- Detail oriented to help with the review of documentation for errors or data required in relation to procedures.
- Knowledge of documentation requirements for 21 CFR 820 (FDA) and ISO (13485) is preferred.
- Proficiency with Microsoft office suite of products.
- Minimum of High School diploma required
- 5-10 years documentation experience in a regulated industry required (i.e.: ISO, Medical Device, Military/DOD, Automotive)
Required Knowledge and Skills: