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Document Control Coordinator
2 months ago
Join an innovative international biotech leader specializing in cutting-edge cell culture media and biopharmaceutical products We're seeking a dynamic Quality Assurance / Document Control Coordinator to play a pivotal role in ensuring excellence in the quality assurance / document control operations. In this contract role, you'll be at the forefront of maintaining and processing Standard Operating Procedures and other critical documents, contributing to our mission of advancing biotech solutions globally.
The Document Control Coordinator will be responsible for, but not limited to:
- Word processing of controlled documents.
- Maintaining Document Control system for the revision of controlled documents.
- Supporting GMP records management program.
- Supporting the document control program.
- Supporting GMP labeling requirements.
- Ensuring compliance to ISO 13485, QSR, MDD 93/42/EEC, IVDD 98/79/EC, TGA, and Canadian Device Regulations.
Requirements:
- High school diploma or equivalent.
- A minimum of two (2) years’ experience of Quality Assurance Document Control in a medical device manufacturing environment or equivalent.
- Computer skills, specifically MS Word, Excel, Outlook, Gmail.
- Current industry regulations, e.g. cGMP, ISO 13485, 21 CFR Part 820, TGA and Canadian Medical Device Regulations.