Hybrid QA Lead - Product Development (Pharma)

AbbVie Inc.; North Chicago (IL); Híbrido; USD 79.000 - 141.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Paid time off

Medical/dental/vision insurance

401(k)

Descripción de la vacante

AbbVie Inc. in Chicago seeks a Senior Associate, Product Development Quality Assurance to support batch disposition and ensure clinical supplies meet global regulatory standards.

The role partners with multiple functions to mitigate risk and review batch documentation for timely release. The successful candidate will manage multiple tasks, adapt to supply needs, and provide quality oversight on the manufacturing floor as needed.

Formación

• Bachelor’s degree in life sciences (biology, chemistry, or engineering) or equivalent.
• 4+ years of industry experience in Quality Assurance, production, or testing in healthcare fields.
• Broad understanding of pharmaceutical manufacturing processes (chemical and biological) and GMP (D, EU, US).
• Experience coordinating and planning complex activities.
• Proven organizational skills and ability to handle conflicting priorities.
• Strong written and oral communication to advocate for quality.
• Ability to identify and resolve complex problems using technical and interpersonal skills.

Responsabilidades

• Review and approve batch records and release batches or analytical records.
• Lead/assist in audits conducted by regulatory agencies, customers, and R&D GxP Compliance.
• Provide quality approvals in materials management systems and manage CAPAs and deviations.
• Review/approve clinical documentation and specifications as applicable.
• Lead/participate on project teams to support product development and resolve quality issues.
• Generate and report quality metrics to management and assist in QA timelines.
• Monitor process effectiveness and drive quality improvements across projects.
• Provide quality oversight on the manufacturing floor when needed.

Conocimientos

Quality Assurance

GMP knowledge

Audit coordination

Documentation & record review

Interpersonal leadership

Problem solving

Educación

Bachelor’s degree in life sciences

Descripción del empleo

AbbVie Inc. in Chicago seeks a Senior Associate, Product Development Quality Assurance to support batch disposition and ensure clinical supplies meet global regulatory standards.

The role partners with multiple functions to mitigate risk and review batch documentation for timely release. The successful candidate will manage multiple tasks, adapt to supply needs, and provide quality oversight on the manufacturing floor as needed.