QA Specialist

About the role

We are Abzena—more than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The QA Operations Specialist will support the Abzena operations teams to drive continuous improvement and operational excellence throughout the organization. This individual will be a primary point of contact for Batch Disposition, Quality Control, and Quality Record escalations, as well as document review and approvals.

Responsibilities

• Act as BPO for the Batch Disposition process at Abzena San Diego, including ownership of the overall Disposition process, support on the creation of Disposition Packets, and cross-functional collaboration to obtain required key deliverables. Partner with the Project Management Organization (PMO) and clients to ensure all requirements are met.
• Support the Quality Control (QC) Organization in laboratory data, protocol and report review, implementation of QC CAPAs, and handling of Out of Specification (OOS) and Over Action Limit (OAL) quality events.
• Support the disposition of Bulk Drug Substance, Bulk Intermediate, Research Cell Banks (RCB), Master Cell Banks (MCB), and Working Cell Banks (WCB) to enable forward processing in manufacturing.
• Serve as the primary point of contact for engineering and facilities for quality-related actions.
• Act as a subject matter expert (SME) for batch record review and disposition of buffers/media manufactured by Abzena.
• Support client batch record review processes and aid in responses to client findings.
• Support Operations groups in initiation, investigation, and approval of Deviations, Change Controls, CAPAs, ILIs, and OOSs as applicable.
• Review and approve Standard Operating Procedures (SOPs), Master Batch Records (MBRs), Quality Control Protocols and Reports, etc.
• Support regulatory and client inspections, providing guidance on responses, including root cause and CAPA plans.
• Author Major deviations, Change Controls, and CAPAs as required on behalf of Quality Assurance.
• Attend daily meetings such as Manager Work Center Team (WCT), Deviation triage, etc., on behalf of Quality Assurance.
• Work cross-functionally with other departments for metrics reviews, operational support, and quality system management.
• Identify and drive continuous improvement opportunities throughout the organization utilizing LEAN ideologies.
• Partner with stakeholders to drive a quality mindset and culture.
• Perform other related QA duties as assigned, including supporting QA on the floor.

Requirements

• Minimum of a B.S. degree in Life Sciences or Engineering with 4+ years of experience in a GMP-regulated Biopharmaceutical facility or equivalent.
• Demonstrated proficiency in technical operations in manufacturing/engineering and ability to drive quality improvements.
• Experience with driving lean projects and principles to foster continuous improvement.
• Experience in batch record review, quality records, and disposition activities.
• Knowledge of industry standards and regulatory requirements for biologics and parenteral products in clinical development and commercial settings.
• Knowledge of GMP regulations, good documentation practices, cGMP, 21 CFR, USP, and other applicable regulations, standards, and guidance.
• Ability to work in a cross-functional, fast-paced environment.
• Ability to manage a team and ensure development of respective associates.

Pay

$90,000 - $125,000 a year