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.
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.
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
APN Software Services, Inc .
39899 Balentine Drive, Suite 385, Newark, CA 94560 .
| Fax: 510.623.5055 | Email: firstname.lastname@example.org