Design Quality Staff Scientist

Here is a brief job description:
Assist in designing and coordinating quality control systems that are tailored for specific product assays across the Business Units. Work with Medical Affairs, R&D, Technical Operations, and Manufacturing to create a QC system ensuring that our products meet customer expectations, as well as regulatory, proficiency, and manufacturing requirements over the life of the product. 
 Responsibilities:* 
 Create and implement best practices in quality control system development.* 
 Document these approaches for use in all business units in the diagnostics division.* 
 Assure long term sustainability of best practices for commercial product.* 
 Participate in technical and design reviews to assure excellence in developing quality control release specs by the project teams.* 
 Review and approve Control System design reports. 
 Desired Qualities: 
 Reputation for excellence in Life Science or IVD Product Development.* 
 Sound knowledge of data analysis and assay performance evaluations.* 
 Understanding of basic statistics. 
 Ability to understand complex issues and translate into operable experiments and solutions leading to robust linkages between assay optimizations, design spaces and manufacturing release specifications.* 
 Ability to work independently and in project teams.* 
 
 Excellent communication skills (written and spoken) *Required Education:* PhD degree in the sciences and 5 years of experience or MS or BS with 10 years of experience, preferably in an IVD R&D environment. Experience with Immunoassay design desired. 
 Required Travel:* 25%

I look forward to hearing from you
 
Cordially,
 
Mohammed Abdul
 APN Software Services, Inc .
 39899 Balentine Drive, Suite 385, Newark, CA 94560 .
 Direct: 510.623.5049
| Fax: 510.623.5055 | Email: abdul@apninc.com

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