Ambry Genetics

Quality Compliance Specialist

Ambry Genetics

7 Argonaut, Aliso Viejo, CA 92656, USA
Full-TimeDepends on ExperienceMid-LevelBachelors
Job Description

Manage the Supplier and Vendor Management Program and ensure compliance with all relevant quality management systems. Interact with cross-functional departments to provide quality guidance and training on supplier management quality and regulatory requirements. Provide oversight and facilitate timely closure of SCARs, Non-conformances, Deviations, and CAPAs related to supplier quality issues.Conduct supplier quality related investigations thorough root cause analysis. Execute part number and specifications process while ensuring the maintenance of the part numbering data base. Conduct internal and supplier audits including executing audit plan, report, and follow-up on response closure. Support regulatory and accrediting body inspection activities and represent the Supplier Management Program as a subject matter expert. Write, revise, and review controlled documents and training materials to support supplier and vendor management and audit program.

Where is this job?
This job is located at 7 Argonaut, Aliso Viejo, CA 92656, USA
Job Qualifications
  • Supplier Management and Audit knowledge in a medical device/IVD organization desired

  • Knowledge of international, US Federal, state laws, and standards (FDA, CLIA, CAP, NYS, ISO)

  • 5+ years in a life sciences discipline with a focus on Supplier Management QMS and Auditing

  • Quality related training/certification (CQA-ASQ) desirable

Required Skills
  • MS Visio

  • MS Project

  • Supplier management

  • Great time management

  • Excel skills

  • PowerPoint skills

Soft Skills
  • Team player

  • Verbal communication

  • Prioritizing skills

  • written communication

  • Flexibility/Adaptability

  • Attention to detail and accuracy

  • Multi tasker

Compensation

According to JobzMall, the average salary range for a Quality Compliance Specialist in 7 Argonaut, Aliso Viejo, CA 92656, USA is $60,000 to $100,000 per year. This range is based on the experience and qualifications of the specialist. Factors such as the size and complexity of the company, as well as the amount of experience and qualifications of the individual, can affect the salary range.

Additional Information
Ambry Genetics is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedMarch 14th, 2022
Apply BeforeMay 22nd, 2025
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About Ambry Genetics

As a company built by scientists, genetic counselors and physicians, we are your partner in genetics and genomics.

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