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Senior Associate, Product Development Quality Assurance-Hybrid, Chicago at AbbVie · LumiJobs

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AbbVie· Posted Oct 30, 2026

Senior Associate, Product Development Quality Assurance-Hybrid, Chicago

North Chicago, IL, United Statesfull time

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On Site

senior

H1B: yes

AbbVie Senior Associate, Product Development Quality Assurance at AbbVie supports batch disposition activities ensuring clinical supplies meet global regulatory standards. The role involves reviewing batch records, managing audits, and leading quality improvements.

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.
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.

Qualification

Bachelor’s degree

Required

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 healthcare-related field