Job ID :
US - Massachusetts - Bedford
- Initiate and administrate workflows in Oracle Agile system upon receipt of revision requests for all controlled document types (SOPs, forms, Quality Standards, Specifications, BOMs)
- Issuance of revised documents including archival of superseded documents. Initiate routine document review workflows for controlled document types (SOPs, forms, quality standards)
- Maintains training record, administrate training assignment resulted from change control. Create and maintain training matrix. Support other training processes as needed.
- Review and approve production and quality control Batch Records. Perform batch release including: labeling, ERP transactions, document control, filing and other related tasks.
- 3+ years of related work experience in quality assurance, document control, data entry and office administration
- Knowledge of ISO9001 or 13485 document version control processes, policies and procedures
- Ability to work independently or as part of a team, self-motivated, adaptable
- Excellent communication and attention to detail
- Experience with Oracle Agile PPM, Spartan TrackWise, SAP ERP/QM/LMS or other major electronic QMS tool highly desired
- GMP Quality Assurance experience highly desired
- Bachelor’s Degree a plus