Overview
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
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 and document review and approvals. Key responsibilities will include supporting on the floor production, performing batch record review, supporting of quality records and controlled documents, and acting as a BPO of multiple quality operation processes. This position will collaborate will all departments throughout Abzena and should be focused on teamwork, cross-functional collaboration and driving a quality culture.
Responsibilities
- Act as BPO for the Batch Disposition process at Abzena San Diego. This includes ownership of the overall Disposition process, support on the creation of Disposition Packets, and the ability to work cross functionally with other departments to obtain the required key deliverables. This individual will need to work with the Project Management Organization (PMO) and partner with clients to ensure all requirements are met and information is cascaded accordingly.
- Support the Quality Control (QC) Organization in laboratory data, protocol and report review, provide and support implementation of QC CAPAs, and support QC on Out of Specification (OOS) and Over Action Limit (OAL) quality events.
- Support the disposition of Bulk Drug Substance, Bulk Intermediate, Research Cell Banks (RCB) and Master Cell Banks (MCB) and Working Cell Banks (WCB) to enable forward processing in manufacturing.
- Be the primary point of contact for engineering and facilities for quality related actions.
- Be an SME of batch record review and disposition of buffers / media manufactured by Abzena.
- Support client batch record review processes and aid in the responses to client findings.
- Support Operations groups in initiation, investigation and approval of Deviations, Change Controls, CAPAs, ILIs and OOSs as applicable.
- Support Operations groups in the review and approval of Standard Operating Procedures (SOPs), Master Batch Records (MBRs), Quality Control Protocols and Reports, etc.
- Support regulatory and client inspections and provide guidance on responses, including root cause and CAPA plans as applicable.
- 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 throughout the organization to drive quality mindset and culture.
- Performs other related QA duties as assigned including but not limited to supporting QA on the floor.
Qualifications
- Minimum of B.S. degree in Life Sciences or Engineering with 4+ years of experience in a GMP regulated Biopharmaceutical facility or equivalent.
- Demonstrated proficiency of technical operations in the manufacturing / engineering space and ability to drive quality improvements within the organization.
- Experience with driving lean projects and principles within an organization to drive continuous improvements.
- Experience in batch record review, quality records and disposition activities.
- Knowledge of industry standards and regulation requirements for biologics and parenteral products in clinical development and commercial.
- Knowledge of GMP regulations, good documentation practices, cGMP, 21CFR, USP and other applicable regulations, standards, and guidance.
- Ability to work in a cross-functional environment and resilience to a fast-paced environment.
- Ability to manage a team and ensure development of respective associates.
