Quality Assurance Manager
- Job ID:
- Date:07/21/2008
- Location:Etowah
- State:Tennessee
- Degree:B.S./B.A.
- Salary:Not Specified Why?
- Job Types:
-
TRAINING
Job Description
To Manage the Etowah Quality system and supervise the laboratory technicians in providing technical support to production and to assist the Operations Supervisors in resolving process problems and implementing process and production changes. Manage the quality functions of the plant to assure the maintaining and sustaining of quality goals in support of both company and ISO standards. Provide support and direction to allow for process and quality improvements to facilitate positive action plans. Function as a technical liaison with both internal and external customers in the resolution of technical problems related to products, processes or applications. Exhibit technical competence to allow for both written and oral communications with customers, management, peers and associates. To be responsible for the Quality assurance of the flow from raw material until finished product and for determining the quality management policy for quality assurance and quality control.
1. Implement and sustain the Quality management system and ensure a clear quality approach and mindset in the plant. Ensure that Quality mindset is implemented throughout the entire plant. 2. Implement and sustain the ISO 9000:2001 certificate. Change the organization from departmental ISO mindset (ISO 9002) to process management mindset (ISO 9000:2001). Provide trained auditors for the facility in accordance with ISO System requirements. 3. Evaluate and organize audits (internal, external, customer, product,) and initiate actions in cooperation with the coworkers. 4. Responding to customer concerns, feedback, and/or complaints in a prompt and effective manner. Follow up of actions resulting from customer feedback throughout the organization. 5. Supervises all product and raw material testing; ensures that all necessary control tests are performed utilizing standard laboratory procedures so as to allow product shipments within established guidelines.
6. Establishes technical work priorities allowing for proper utilization of Laboratory Technicians. Ensures that laboratory technicians are properly trained in accordance with established laboratory procedures. Evaluates work performance, promotes qualified employees; takes first step disciplinary actions to notify Engineering and Quality Manager; schedules rotating shift personnel; approves time cards. Will supervise chemist and analytical lab technicians.
7. Establishes new laboratory techniques that will improve the accuracy and speed of analysis. 8. Maintains ongoing knowledge of all analytical laboratory procedures and equipment. 9. Ensures the laboratory record keeping by keeping precise, accurate and orderly records. Organizes the data in report form to allow proper plans of action.
Requirements 1.BS in Chemistry or six years of supervisor experience within a laboratory setting. 2.Working knowledge of Microsoft computer systems. 3.Must be qualified on the basis of education, training and/or experience for all actives affecting quality. Evidence of this qualification shall be demonstrated by any of the following: a) ISO Lead auditor training, b) ISO auditor training, c) at least six months experience as quality manager at an ISO certified facility. 4. GMP (Good Manufacturing Practices) experience in excipient manufacturing.
(62748)
