Role Overview
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This role will support the day-to-day operations of a Quality Control Laboratory to ensure adherence to quality and safety standards within the laboratory.
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Key Responsibilities:
1. Investigate and document lab errors in accordance with standard operating procedures (SOPs)
2. Complete human error investigations
3. Support the implementation of corrective action preventive actions (CAPAs)
4. Participate in the QC compliance walkdown program
5. Report on the outcome of the compliance walkdown program on a monthly basis
6. Support the QC department in preparing for internal and external audits
7. Act as a QC representative on the site's Virtus (Quality Continuous Improvement) Team
8. Generate PQR reports for the QC department on a bi-annual basis
9. Manage compendia changes
10. Identify and support continuous improvement activities within the QC department
11. Complete CAPA, change plan, audit tasks in accordance with site timeliness requirements
12. Support the preparation and review of QC department reports and metrics
13. Support the Senior Support Analyst through Compliance Wire administration and onboarding training
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