Robert El-Shafey
- Role
- Quality Assurance Specialist Ii at AstraZeneca
- Location
- Frederick, MD, US
- LinkedIn followers
- 500 followers
About Robert El-Shafey
Experienced Quality Assurance professional with 7+ years in biologics manufacturing…
Experience
Quality Assurance Specialist Ii
Oct 2021 — Present
Reads, understands, and follows SOP’s and complies with cGMP’s Writes new standard operating procedures or revises existing documentation utilizing document management systems Supports the evaluation and disposition of labeling, raw materials, intermediates and finished products through timely evaluation of batch records, laboratory results and other cGMP documents Supports the issuance and reconciliation of GMP documentation Electronic system usage with tools such as Trackwise, GQCLIMS, Pas-X and SAP Reviews documented information from their functional area, reports abnormalities Assists in the implementation of new processes. Assists supervisor by assembling metrics as requested for their functional area. Provides task-oriented training to Specialists. Initiates and/or reviews and approves minor deviations; completes tasks related to CAPA and Change Control action items. Represents QA on site committees such as SHE, etc. Proposes and implements process and other efficiencies as approved by supervisor.
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