Technical Specialist, MQS

Job description

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Technical Specialist, MQS is responsible for writing records for Avid’s Quality Management System (QMS) including, but not limited to, records for the following: Deviations, out-of-tolerance calibration events, out-of-specification (OOS) results, out-of-limit (OOL) results, and out-of-trend (OOT) results. This role performs investigations required to write these records and for routing/tracking records from assignment to approval. Identifies and implements corrective and preventive actions (CAPAs), as applicable. Where issues or improvements are identified, this role works with subject matter experts to propose viable solutions including a final product impact assessment. Identifies elements that can be made more efficient, are potential sources of discrepancies, require ‘fine-tuning’, or need a complete revision. - Adhere to Good Manufacturing Practice (GMP) regulations (21 CFR, Part 211) a...