Supplier QA Analyst

AbbVie•Irvine, CA

11h

About The Position

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. Purpose: This role is responsible for Supplier Quality at the BLI site, to ensure the quality of purchased materials and managing the supplier audit and maintenance processes. The individual enables and supports supplier QA activities by coordinating supplier introduction, maintenance, investigations, corrective actions, audit preparation and execution, and change management. The analyst maintains accurate supplier and audit records in OneTrack, supports policy and procedure updates, and serves as a key liaison between suppliers, site teams, and the global supplier quality COE to ensure compliance with corporate and regulatory requirements.

Requirements

Bachelor’s degree in Microbiology, Biochemistry, Engineering, or a scientific discipline.
Minimum 2 years of experience in a supplier controls role in the biopharmaceutical manufacturing industry.
Technical and professional skills including good verbal and written communication, problem solving, analytical, interpersonal, and negotiation skills.
Strong computer skills in Microsoft applications (Word, Excel, Access, PowerPoint).
Experience analyzing data and trends, drawing sound conclusions to ensure business unit compliance.

Nice To Haves

Experience with TrackWise and Veeva Vault preferred.

Responsibilities

Coordinates and resolves quality and performance issues with suppliers, Manufacturing Quality Assurance, and other stakeholders.
Manages implementation of new and existing processes impacting vendor product quality assurance.
Establishes and documents contact with suppliers regarding quality issues (e.g., nonconformity, deviation, defect report).
Performs assessment and manages review of supplier change notifications for incoming materials.
Assigns actions as appropriate to local cross-functional team.
Manages Approved Supplier List by maintaining supplier records in OneTrack and OneVault, including but not limited to quality agreements, material content statements, specification agreements, supply chain documentation, change records, assessments, and certifications.
Coordinates quality questionnaires with suppliers.
Maintains internal quality agreements within the AbbVie network.
Coordinates with material management to maintain SAP or other quality systems with current specifications, approvals, supplier status, and audit records.
Facilitates and manages the audit preparation process for scheduled periodic supplier audits, ensuring user sites and impacted teams are prepared.
Reviews and processes audit and change requests, following up for additional information as needed.
Provides technical input and support for updates to policies and procedures, and change management requests at both the site and global level.
Supports questions and provides guidance to internal stakeholders regarding supplier audits and processes; escalates issues as required.
Maintains supplier performance metrics for monthly and quarterly management review.
Participates in department continuous improvement efforts and cross-functional projects.
Monitors department budget, and escalates issues as needed.