Manager, Quality Assurance

2 weeks ago


North Chicago Illinois, United States AbbVie Full time
Job Description

Responsibilities

Defines strategy for staff to manage daily activities for planning and implementing the LRP. Manages direct reports including hiring, setting performance expectations, reviewing performance and developing staff to support the Quality needs of the plant. Evaluates and develops tools to enable staff to continually improve performance and maximize productivity

Supports internal and external audits, providing responses and developing improvement plans

Provides an active role in implementation of policy and procedure in support of the Quality System for the plant. Reviews and approves Quality system documents and records

Leads or participates in strategic initiatives to improve the following when possible:

-Batch record review and release

-VCRs and validation protocols

-Lot disposition and/or finished goods and/or commodities

-APRs/PQRs

-Quality metrics

-Track and trend activities

-Change management

-Risk management

-Training

-Data integrity

Responsible for ongoing compliance with and understanding of applicable policies and procedures, including GMP

Performs in-process testing to support Quality on the manufacturing floor

Provides feedback and oversight for complaints, non-conformances and deviations, identifying improvements and responding to trends

Act as authorized person for product release to market

TPM and TPC Quality management, including exception requests (ERs),change requests (CRs) and QTA

Tests commodities and raw materials for product compliance and manages retained samples.

Reviews and releases batch records.

Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)



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