Job Description
Our client, a Biopharmaceutical company, is looking for a QA Specialist – II for their Oceanside, CA location. Responsibilities:
+ Perform Quality Assurance related production and production related activities (Batch Record review, Line Clearance, and on the floor support)
+ Provide Quality oversight/approval of Quality Control activities (Method transfer, Certificate of Analysis, nd Stability)
+ Approve shipments and provide oversight during packaging of product
+ Ensure timely assessment and closure of discrepancies, Deviations, CAPAs and Change Controls
+ Ensure timely assessment and closure of Laboratory Investigations
+ Ensure timely assessment and closure of batch and material hold events
+ Communicate lot disposition pending issues to Management
+ Provide on-the-floor QA oversight and support to ensure compliance to GMP throughout the areas
+ Perform walk-throughs and process observati...