- BSc with 1+ years of related QA experience
- GCP or GLP knowledge is an asset
- English communication and writing skills necessary for this role
- Archive records (paper and/or electronic) in accordance with established Standard Operating Procedures (SOPs) and the applicable Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) principles (not a must have but preferred)
- Ensure that access to the archives is controlled
- Ensure that the orderly storage and retrieval of records and materials is facilitated by a system of indexing
- Ensure that the movement of records (study and non-study specific, paper or electronic) in and out of the archives is properly controlled and documented
- Scan paper documents and file electronic records accordingly
- Assist in the retention of documentation both paper and electronic in controlled-access locations.
- Assist in the administration of the QA training program
- Assist in the preparation for audits, organizing files and documentation
- Interface with document management vendor for file retrieval and returns
- Familiarity with archival requirements in a GCP/GLP regulated environment, and knowledge of good documentation practices preferred
- Highly proficient in reading, writing, and communicating in English
- Ability to perform well in a team-based work environment by being reliable, cooperative, collaborative, open, and positive
- Strong attention to detail
- Experience using Microsoft Office products: WORD, Excel, Outlook, PowerPoint and SharePoint
Quality Assurance Document Associate - ContractMontreal, QC, Canada
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QUALITY ASSURANCE DOCUMENT ASSOCIATE - CONTRACT
Category: Biotechnology & Pharmaceutical
Reference ID: CA7677BM001367
Date Posted: 09/05/2019