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Manager of Manufacturing Quality Assurance Job
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| Employer Name: ManufacturingCrossing |
SpiderID: 2275098 |
| Location: Greenville, South Carolina |
Date Posted: 6/12/2008 |
| Wage: |
Category: Manufacturing |
| Job Code: 5374951 |
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Job Description:
The chosen candidate will be reporting directly to the Site Quality Director. Responsible for management of QA Line operations, Receiving Inspections, Quality Engineering and Supplier Quality performance improvement processes to ensure FDA and ISO Compliance for Greenville Operations. Reporting directly to this position will be two Manufacturing Quality Assurance Shift Supervisors and one Quality Engineer. This position requires a strong background in Pharmaceutical or Medical Device Quality Management. H/She will insure the reporting of timely and detailed non-conformance investigations. Requires demonstrated root cause analysis, investigation and technical report-writing skills. Responsible for staff development to focus on process improvement and the use of basic and advanced quality engineering tools such as SPC and DOE. Candidate will provide leadership to Operations on cGMP and other compliance requirements. Previous experience as a direct interface during FDA inspections is a plus. Job Duties: Manage MQA line inspection supervisors, including receiving Inspections. Ensure Material and Quality System investigations and technical issues are resolved in a timely manner and in compliance with current agency and industry standards. Propose and implement systemic corrective actions. Lead Supplier Management Team (SMT) with the goal of driving continuous improvement in supplier quality performance and to support timely resolution of supplier nonconformance issues. Candidate will use Lean/Six Sigma tools to support manufacturing in identifying areas of improvement. Quality Assurance Skills: Bachelors Degree in Chemistry, Microbiology, Biology or related scientific discipline is required. 8+ years experience managing quality systems in a sterile pharmaceutical or medical device facility. Experience as an internal or external auditor and in conducting investigations. Experience as direct interface with FDA during inspections a plus. Experience and working knowledge of FDA, ISO, EU requirements are a plus. Experience and working knowledge of ICH, WHO, PIC/S guidance and regulations are a definite ++. Special Skills Demonstrated knowledge of management of Quality operations and processes. Demonstrated technical writing ability and proficient computer skills are required. Demonstrated success in the cultivation and development of direct reports. Strong analytical and problem solving skills, especially in non-conformance investigations.
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For further information, please visit us online at http://www.manufacturingcrossing.com
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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: - |
Company Type: Employer |
| Company: ManufacturingCrossing |
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| City: Pasadena |
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| State: California |
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| Zip: 91101 |
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Web Site: http://www.manufacturingcrossing.com
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