Get Our FREE Industry eNewsletter

CLIA Manager QA/QC

Theranos, Inc.

Newark , CA
Posted Date:
Position Type:
Full time
Job Code:
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


• 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

By applying to/saving a job using , you are agreeing to comply with and be subject to the Terms of Use for use of our website. To use our website, you must agree with the Terms of Use and both meet and comply with their provisions.