Quality Assurance Specialist I (Hybrid)

Quality Assurance Specialist I (Hybrid)

This individual will be responsible and accountable for quality tasks and operations within the supplier management program under the Quality Management System (QMS). Supports the program by processing supplier questionnaires and reviewing responses to complete qualification summary reports. Preferred experience with CLIA, CAP, FDA, and ISO requirements and working in compliance in these regulated environments

Essential Function

• Communicate with current and new suppliers via requesting completion of questionnaires.
• Review the information suppliers provided and evaluate responses to ensure it meets Ambry’s requirements.
• Clearly organize and summarize supplier information within a qualification summary report within EDMS.
• Research and gather information about suppliers to aid in completing annual quality score card for suppliers.
• Request and maintain quality metrics for reference laboratories as needed.
• Assist in communicating complaints to suppliers via Supplier Corrective Action Request (SCAR) document.
• Review the supplier’s response to the SCAR document to evaluate if it meets Ambry’s requirements and close out records in accordance with the CAPA program.
• Assist in preparation for on-site audits. May support internal audits as needed.
• Demonstrate teamwork and collaboration to ensure effective communication within QA team and among other departments.
• Other duties as assigned

Qualifications

• Bachelor of Science degree in a life science discipline is strongly preferred.
• Proficient MS office programs (Word, Excel, PowerPoint, Visio, Projects, and Outlook).
• Demonstrated technical writing skills, including third-person narratives, technical summaries, and the ability to clearly outline processes/workflows in universally understood language.
• Demonstrated problem solving and critical thinking skill.
• Ability to work independently and multi-task, with strong decision making skills.
• Strong ability to learn and navigate electronic systems.
• Strong written/verbal communications, interpersonal, and relationship building skills required
• 2+ years of experience in a quality/compliance/regulated science related industry.

Compensation: $29.08 hourly, Eligible for a Short-Term Incentive with a target at 5% of annual earnings; terms and conditions apply.

About Us:

Ambry Genetics Corporation is a CAP-accredited and CLIA-licensed molecular genetics laboratory based in Aliso Viejo, California. We are a genetics-based healthcare company that is dedicated to open scientific exchange so we can work together to understand and treat all human disease faster.

At Ambry, everyone is welcome. A career at Ambry Genetics is a chance to be part of a dynamic company that aims to improve health by understanding the relationships between genetics and human disease. We earned our reputation as industry leaders by responsibly introducing cutting-edge genetic testing solutions and continually sharing what we learn with the global scientific community.

At Ambry you will be learning, challenging yourself, and having fun while collaborating with teammates through the open exchange of ideas.  Our outstanding benefits program includes medical, dental, vision, FSA, paid sick leave and generous paid time off (PTO) program. You can learn more about the benefits here. Ambry Genetics is an Equal Opportunity Employer (EOE) and we maintain a drug-free work environment.

The Company believes in second chance employment.  Qualified applicants with arrest or conviction history will be considered regardless of their arrest or conviction history, consistent with local laws such as Los Angeles County Fair Chance Ordinance and the California Fair Chance Act.  You do not need to disclose your criminal history or participate in a background check until a conditional job offer is made to you. After making a conditional offer and running a background check, if the Company is concerned about conviction that is directly related to the job, you will be given the chance to explain the circumstances surrounding the conviction, provide mitigating evidence, or challenge the accuracy of the background report. For the purpose of the above job description, “Essential Functions” are “Material Job Duties”.

Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.

All qualified applicants will receive consideration for employment without regard to race (and traits historically associated with race, including, but not limited to hair texture and protective hairstyles such as braids, locks, and twists), color, creed, religion, sex, sexual orientation, gender identity, gender expression (including transgender status), national origin, ancestry, age, marital status or protected veteran status and will not be discriminated against on the basis of disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. If you have a disability or special need that requires accommodation, please contact us at careers@ambrygen.com

Ambry does not accept unsolicited resumes from individual recruiters, third party recruiting agencies, outside recruiters or firms without an executed contract in place. We are not responsible for any fees related to resumes that are unsolicited or are received by Ambry. Such resumes will be deemed the sole property of Ambry and will be processed accordingly.

PRIVACY NOTICES

To review Ambry’s Privacy Notice, Click here:   https://www.ambrygen.com/legal/privacy-policy

To review the California privacy notice, click here: California Privacy Notice | Ambry Genetics

To review the UKG privacy notice, click here: California Privacy Notice | UKG

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