Provides temporary administrative support for Quality Assurance processes as defined under Key Responsibilities below.
Key Responsibilities:
The responsibilities of this position may include, but are not limited to, the following:
- Creates Certificate of Analysis and Release data files within the electronic document management system (EDMS) and coordinates review with Quality representative
- Performs Archival of QA Records in EDMS (e.g., CMO batch records, data packages)
- Conduct follow up on Action Items for Quality Leadership Team (QLT) meetings
- Assist with quarterly updates for Continuous Improvement Projects and Risk Trackers
- Assist with generation of Metrics and Metrics reports
- Performs Data Entry into GxP Regulated Systems as required
- Manages events/CAPAs in electronic quality management system (EQMS), including data entry, tracking, and follow-ups with Owners to drive completion
- Coordinates document approval and creates Docusign workflows, as necessary
- Schedules and coordinates meetings for CMC Quality Operational team (Leadership meetings, Extend group meetings). Manages agenda and minutes and follows up on all action items
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