Senior Associate, Product Development Quality Assurance-Hybrid, Chicago

- About AbbVie

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.

This role is primarily responsible for supporting AbbVie’s pipeline, by supporting batch

disposition activities and ensuring high-quality clinical supplies that are compliant with global

regulatory requirements and standards are delivered to patients. This is achieved by effectively

partnering with the business, ensuring risks are mitigated appropriately and supporting efficient

review of clinical supply batches to support continued uninterrupted access to clinical supplies.

The successful candidate will be able to manage multiple tasks and adjust priorities based on

supply needs. This position requires the ability to positively interact with multiple functional

areas quickly and effectively resolve batch record documentation related issues independently,

ensuring schedules are maintained and material is readily available.

Responsibilities

Review and approve batch records and release batches or analytical records. Write/ review/ approve processes/procedures and related documents.; Lead/assist in the preparation and management of audits conducted by regulatory agencies, customers, and R&D GxP Compliance.; Provide quality approvals in the materials management system as defined by procedures. Write, review and/or approve exception documents and product complaints (as applicable), corrective actions/preventive actions (CA/PA) and ensure they meet timeliness requirements.; Review/approve clinical documentation and specifications, as applicable.; Actively lead/participate on assigned project team(s) to support the product development process by using expertise to anticipate/resolve quality issues.; Generate, analyze, and report quality metrics to management. Lead/participate with support groups in developing/prioritizing QA activity timelines.; Actively monitor the effectiveness of processes and quality of project work with management and propose and execute quality/process improvements.; Provide quality oversight on the manufacturing floor, as needed.

Requirements

Bachelor’s degree, typically in life sciences (biology, chemistry, or engineering), and/or equivalent experience.; 4+ years of industry experience in Quality Assurance, production, or testing of active pharmaceutical ingredients, drug products, drug development, or another healthcare-related field, less experience may be considered with an advanced degree.; Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide GMP requirements (D, EU, US) is preferred.; Experience coordinating and planning complex activities.; Proven organizational skills.; Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities.; Effective oral and written communication skills to clearly communicate the quality position and the actions necessary to resolve issues.; Ability to identify and resolve complex problems through effective use of technical and interpersonal skills.