Manager, Quality Assurance
2 weeks ago
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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