Compensation: $25-$30/hr. You are eligible to a Short-Term Incentive Plan with the target at 5% of your annual earnings, terms and conditions apply.

Quality Assurance Specialist I (Hybrid/Onsite-Aliso Viejo, CA)

Minimum of 2 days on site

Job Overview:

This individual will be responsible for leading Quality Management System (QMS) tasks and operations. Execute, maintain, and development of the QMS elements with a focus on Supplier and Vendor Management program, SCARs, Audit program, Quality Event Reporting (QER), and Corrective and Preventative Action (CAPA). The job will require knowledge of Quality Assurance principles, practices, and procedures. Th candidate should have strong written and verbal communication skills to foster cross-functional collaboration and partnerships, lead by positive influence, maintain a high level of integrity, and possess a strong continuous improvement mindset.

Candidate should demonstrate knowledge of regulations, standards, and licensure requirements such as, clinical diagnostic standards: CAP and state licensures; Federal regulations: CLIA (42 CFR 493), FDA (21 CFR 820); Industry standards: ISO 13485 Medical Device-QMS, ISO 15189 Medical Laboratories

Essential Functions:

• Aid in execution of Supplier and Vendor Management Program and ensure compliance with all relevant quality management systems.
• Evaluate suppliers, vendors, and reference laboratories for compliance with internal and regulatory requirements via creation of reports and records as part of supplier qualification program.
• Evaluate, create, and maintain records of suppliers and vendors as part of an on-going quality monitoring program.
• Maintain quality metrics for reference laboratories.
• Assist in evaluation of supplier complaints by providing administration of Supplier Corrective Action Report (SCAR) files and actions to support process owners.
• May assist in conducting internal and external audits including executing audit plan, report, and follow-up on response closure.
• Use critical reasoning skills to participate in, conduct, and review investigations into quality issues.
• Support the migration and implementation of a new electronic document management and assist with steering of new electronic quality management system workflows.
• Support regulatory and accrediting body inspection activities as a subject matter expert.
• Write, revise, and review controlled documents and training materials to support QMS.
• Other duties as assigned

Qualifications:

• Bachelor of Science degree
• Minimum of 2 years of experience in a quality/compliance related field or hard-science related industry
• Experience with quality systems and quality assurance
• Knowledge of international, US Federal, state laws, and standards (FDA, CLIA, CAP, NYS, ISO)
• Strong technical writing skills
• High attention to detail, ability to multi-task with good decision-making skills, and work under deadline pressure
• Have precision in their work, especially as it relates to understanding and documenting complex quality issues
• Excellent time management and organizational skills – must be able to manage several simultaneous projects
• Excellent critical analytical skills- ability to find root cause of why an issue occurred. Ability to review action plans and determine if the actions taken effectively addresses the issue
• Knowledge of technical and analytical laboratory processes
• Proficient MS office programs (Word, Excel, PowerPoint, Visio, Projects, and Outlook)
• Strong written/verbal communications, interpersonal, and relationship building skills required
• Positive and forward-thinking personality and a willingness to continue to learn

Preferred:

• Molecular and/or Clinical Laboratory experience preferred
• Bachelor of Science degree in a life science discipline is strongly preferred

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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, 401k with a 4% employer match, 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.

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.

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