Manager, Product Development Quality Assurance

North Chicago, IL, United Statesfull timeOn Site

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AbbVie Manager, Product Development Quality Assurance at AbbVie responsible for supporting batch disposition activities and ensuring high-quality clinical supplies compliant with global regulations. Manages multiple tasks and mentors peers to resolve batch record documentation issues.

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.
Review draft and final regulation for impact to R&D business and incorporate procedural changes as necessary.
Provide routine area specific management support (act as backup to manager for routine management activities).
Support daily product release activities as applicable to the organization.
Responsible for driving consistency and continual process improvements within PDQA through assessment and compliance of regulations and industry practice.
Write/ review/ approve exception reports, including high impact and complex ERs impacting multifunctional areas.
Actively lead/participate on assigned project team(s) to support the product development.
Actively monitor the effectiveness of processes and quality of project work with management and propose and execute quality/process improvements.
Bachelors (typically in life sciences (biology, chemistry, or engineering) and/or equivalent experience.
Master’s degree is preferred but is not required based on commensurate experience.

Qualification

Master’s degree preferred

Required

Bachelor’s degree typically in life sciences (biology, chemistry, or engineering) or equivalent experience
6+ years industry experience in Quality Assurance, production, testing of APIs, drug products, drug development or healthcare related field

Preferred

Master’s degree preferred
Supervisory/project management experience is a plus

Benefits

Dental
Vision
401(k)
PTO

Company

AbbVie

View company page

10000+ employees

Pharmaceuticals

Founded 2013

Source: smartrecruiters

Active within the past hour

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