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Manufacturing QA Manager
Job Number:
38259422
Company Name:
Hospira
Job Location:
Rocky Mount, NC US
Job Categories:
Healthcare & Medical Manufacturing & Production
Minimum Education:
4-Year College Degree
Manufacturing QA Manager
The MQA (Manufacturing Quality Assurance) Manager maintains responsibility for all aspects connected with plant GMP compliance including the development, analysis and reporting of support data and communications between all regulatory agencies and quality assurance. This individual is directly responsible for managing and coordinating all quality functions on the manufacturing/packaging floor. He/she is responsible for addressing all quality issues in a timely fashion and communicating that information to the support groups as well as the oncoming shift management team. This position has supervisory and indirect supervisory responsibilities.
Requirements:
1. Maintains responsibility for all aspects connected with site GMP compliance. Includes the development, analysis and reporting of support data and communications between all regulatory agencies and Quality department.
2. Reviews and approves all test protocols and data with particular emphasis on those that affect
equipment and facility design and/or operation in the LVS production area.
3. Reviews and approves all manufacturing and control procedures and specifications, as well as provides
the required functional guidance for the development of procedures for the LVS production area.
4. Reviews and approves all investigations and CAPAs for LVS production area.
5. Manages all MQ activities of all shifts through MQ supervisors.
6. Prepares and maintains the budget for all functions in the MQ area.
Requirements:
- Bachelor?s Degree in a related field - 7+ years of experience of manufacturing quality assurance experience - 5+ years as a supervisor in a regulated industry - Experience with the manufacture of solutions and devices in a GMP environment (Gel-caps strongly preferred) - Six Sigma or related statistical process experience is preferred