Quality Assurance Analyst (Laboratory)

Quality Assurance Analyst (Laboratory)

Location: Sunnyvale, CA

Why Ascend?

Come work for a company that is transforming the industry!

We are Ascend Clinical, one of the highest volume clinical laboratories in the United States. With the use of the most advanced tools and technology, we process millions of tests each month. For over 30 years, we have been delivering industry-leading service and excellence in testing. At Ascend, we are relentless about innovation and growing to pioneer the future of clinical and environmental laboratory testing.

Ascend offers the discipline of a healthcare leader and the mentality of a tech startup. Along with our automated laboratory we have internally developed a primary customer-facing platform that assists with managing laboratory services, quality assurance and performance improvement reporting. As a company that is on the leading edge, we are seeking individuals with a similar mindset who enjoy a dynamic, fast-paced environment.

Job Summary:

The Quality Assurance Analyst plays a critical role in supporting the Quality Assurance (QA) department at Ascend Clinical. This position is responsible for generating data analysis reports, supporting quality system activities, and ensuring compliance with regulatory requirements across various platforms including the Quality Management System (QMS), laboratory information systems (LIS), middleware, and electronic document control systems (EDCS). The QA Analyst will report directly to the Quality Assurance Manager.

Responsibilities:

• Support the implementation and maintenance of the Quality Management System (QMS)
• Periodically review laboratory documentation to ensure compliance with federal, state, and local regulation
• Ensure proper archiving of quality and technical records in accordance with regulatory standards
• Assist in the review and maintenance of departmental Standard Operating Procedures (SOPs)
• Support preparation and organization for regulatory inspections and audits; assist with note-taking during inspections
• Participate in investigations and corrective/preventative actions (CAPA) related to nonconformance events
• Prepare and analyze new instrumentation and/or assay validation for quality data review
• Demonstrate proficiency in Laboratory Information Systems (LIS)/middleware and in electronic document control system (EDCS)
• Maintain all phases of the electronic document control system (EDCS), including compliance and continuous education training
• Monitor and verify laboratory personnel acknowledgements of required policies, procedures and worksheets in the EDCS
• Assist with CAP proficiency and linearity evaluation
• Generate, review, and distribute monthly quality control (QC) reports for technical departments
• Monitor laboratory quality control practices and analyze monthly quality indicator metrics for QA meetings
• Coordinate with the Safety Officer to ensure CalOSHA compliance
• Support the maintenance of state licenses and accreditation applications
• Occasionally handle or be exposed to potentially infectious materials in accordance with safety

Qualifications:

• Bachelor’s degree in chemical, physical or biological sciences or medical laboratory science from an accredited institution with at least one year of relevant experience
• Associate’s degree in the same fields is acceptable with a minimum two years of experience
• Experience in Quality Assurance, in a CLIA-certified laboratory preferred
• Familiarity with CA and NY state laboratory requirements
• Working knowledge of CLIA, CA LFS, NY CLEP laboratory licensing programs
• Experience with EDCS platforms and document lifecycle management
• Experience in writing validation plans and summaries is a plus
• Proficiency in in Microsoft Office Suite (Word, Excel, and PowerPoint); experience with EP Evaluator or similar data analysis tools
• Ability to perform statistical analysis and generate quality metric reports
• Strong analytical and problem-solving skills, including root cause analysis
• Excellent organizational skills and attention to detail
• Ability to follow complex instructions and work independently

Compensation:

• $85,000-$105,000

Benefits:

As an Ascend Clinical employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options.

Ascend is an Equal Opportunity Employer - M/F/Disabled/Veteran

Ascend Clinical, LLC is committed to promoting an equal employment opportunity workplace environment and is an equal opportunity employer. It is the policy of the company that all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, citizenship, pregnancy, genetic information (GINA), disability, military and/or veteran status, and/or any other status protected by applicable Federal, state, or local law. The company’s policy is to recruit, hire, train, promote and administer all employment-related matters on the basis of an individual's qualifications, abilities and efforts without regard to protected status.

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