Quality Control Manager Job in Bothell 98021, Washington Us
The Quality Control Manager will oversee the development and implementation of analytical standards, methods and procedures for evaluating the quality and reliability of company products. Perform activities in concordance with FDA Quality System Regulations and ISO-9001 standards; ensure accuracy and traceability of data. Select, develop and evaluate personnel to ensure the efficient operation of the function. Serve as a technical expert for analytical methods and instruments used.
- Hire, train and supervise lab personnel to support QC activities.
- Provide guidance for performance of hands-on material testing and troubleshooting.
- Generate written standard operating procedures to define material evaluation methods and improve workflow and organization of QC documentation.
- Review records and documents for completeness and compliance with QSR and ISO requirements; assure good documentation practices.
- Manage stability studies for Cepheid products.
- Track and investigate OOS/Deviations/Investigations and Change Control activities related to the analytical documentation and testing.
- Develop and maintain QC metrics to track testing capabilities and workflow.
- Develop and maintain the QC system to track Reference Materials and Retains.
- Assure materials' stability; troubleshoot materials issues as necessary.
- A minimum of a Bachelor's degree in Chemistry, Biochemistry, or similar field. Or, equivalent combination of education and experience to perform at this level.
- A minimum of 5 to 8 years experience in analytical methods development or quality control in a biotechnical or chemical organization.
- Previous supervisory experience (a minimum of 1-2 years) is required.
- Expertise in analytical method development, including HPLC and Mass Spectrometry methods.
- Working knowledge of GMP, ISO, and QSR regulations.
- Excellent verbal and written communication skills.
- Effective interpersonal skills; ability to interface with a variety of departments and organizational levels.
- Computer skills, including thorough knowledge of Excel and Word.
- Effective problem solving and analytical skills.
- Effective organization and planning skills.
If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=1304647-1789-3072
February 10, 2009
• Tags: Quality Control Manager Job in Bothell 98021, Washington Us • Posted in: General