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Quality Assurance Specialist II or III

Verinata Health, Inc.

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Location: Redwood City, CA Posted Date: 4/18/2013 Position Type: Full time Job Code: 3941831 Salary: DOE Required Education: Bachelors Degree Areas of Expertise Desired: Molecular Biology

Description

Verinata is driven by a sole, extraordinary purpose — maternal and fetal health. Our initial focus is to develop and offer non-invasive tests for early identification of fetal chromosomal abnormalities using our proprietary technologies. We aim to reduce the anxiety associated with today’s multi-step process, the unacceptable false-positive rates, the non-specific and sometimes confusing results of current prenatal screening methods, as well as the risk of current invasive procedures. In support of national guidelines recommending first trimester aneuploidy risk assessment, we believe women who desire such an assessment should be offered a single blood draw test with a definitive result. Verinata has completed its blinded pivotal study to clinically validate the sensitivity and specificity of its first prenatal test. The verifi™ prenatal test is a non-invasive assay for the determination of the three primary chromosomal aneuploidies for trisomies 21, 18 and 13.


Our company is located in Redwood City, CA. We are looking for enthusiastic and self-motivated talent with demonstrated experience in working in a collaborative environment to further advance maternal and fetal health care. This opportunity to work within a small entrepreneurial team offers tremendous growth opportunities, with competitive benefits and compensation.

POSITION SUMMARY

The QA Specialist II-III position supports quality assurance activities related to quality system compliance and continuous improvement specifically with regards to IVD products. The ideal candidate will have a Quality Assurance background in an in vitro diagnostic company and/or a product development background in molecular biology products or molecular diagnostic products company utilizing nucleic acid technology (e.g. PCR, sequencing, etc) is a plus.

Responsibilities:

•   Must have a thorough understanding of FDA design control compliance requirements for IVD products to ensure that internal design control policies and procedures comply with regulations and external standards, including risk management, and change control.
•   Will be responsible for ensuring the completeness of DHF and confirming compliance of DHF to requirements. This will include maintaining DHF to regulatory requirements.
•   Perform periodic audits of the DHF to evaluate conformance to WIs.
•   Serve as the owner for all processes and procedures related to design control (WIs and QFs).
•   Provide guidance for the application of internal development procedures, including design control, to the product development teams, within the framework of regulatory requirements.
•   Perform trending analysis (Quality Metrics) on an as needed basis, including using statistical process control methods.
•   Work with management to improve quality system policies and procedures.
•   Assist management with preparations for external audits.
•   Product/complaint investigations (as needed).
•   Contribute to NC and CAPA investigations as required.

Requirements


•   B.S. Degree in Molecular Biology or related field plus 6 years of industry experience; in vitro diagnostic quality assurance preferred or
•   A.S./High School Diploma plus 8 years of industry experience; in vitro diagnostic quality assurance preferred.
•   Excellent problem solving and analytical skills.
•   Effective interpersonal and communication skills and capable of supporting cross-functional project goals.
•   A thorough understanding of GDP, GMP and FDA Quality System Regulations especially design control is required.
•   Proven ability to directly lead and/or co-lead multiple tasks and projects is highly desired.
•   Quality engineering experience as well as experience with CLIA is a plus.
•   Excellent problem solving and analytical skills
•   Effective interpersonal and communication skills and capable of supporting cross-functional project goals.

To apply for this excellent career opportunity please submit your resume via link.

Verinata Health is an equal opportunity employer.
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