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CLIA Manager QA/QC

Theranos, Inc.

Location:
Newark , CA
Posted Date:
6/30/2014
Position Type:
Full time
Job Code:
cliam063014
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Development, Manager, Quality, Quality Assurance, Quality Control, Regulatory, Research,

Job Description

• Establish and maintain systems, policies and procedures to ensure product quality and compliance
• Work with R&D and manufacturing to ensure internal groups and outside suppliers meet applicable quality standards
• Ensure that SOPs, MOPs, validations, CAPA's and internal audits are reviewed, approved, implemented and completed in a timely manner
• Ensure compliance of the document control program
• Develop and oversee training program to ensure GMP compliance and internal training requirements
• Develop and oversee validation activities for products, processes, facilities and computer systems including 21 CFR part 11
• Development and oversight of QA/QC budget
• Development of quantitative testing for products from design through commercialization
• Develop stability protocols and studies
• Review analysis of internal and external quality data to detect trends and monitor product quality
• Provide QA oversight of manufacturing, quality and clinical documents that are submitted to regulatory agencies
• Investigate client concerns, identify and implement improvement initiatives in the laboratory environment
• Work with regulatory agencies to ensure the laboratory environment is exceeding standards

Requirements

• 10+ years of QA management experience in the healthcare industry
• BA/BS or equivalent (advanced degree a plus)
• Strong knowledge of CMS and FDA regulations and guidance; knowledge of HIPAA preferred
• Experience hiring and training technical personnel
• Strong communication, leadership, interpersonal and team building skills
• Strong knowledge of Microsoft Office

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