Quality Specialist I - Hybrid: 2 to 3 days on-site (Aliso Viejo, CA)

Compensation: $27.00 - $30.00 per hour. You are eligible for a Short-Term Incentive Plan with the target at 5% of your annual earnings; terms and conditions apply.

Quality Specialist I - Hybrid (Aliso Viejo, CA)

The Quality Assurance Specialist I is responsible for quality tasks and operations related to both document control and general QMS processes. Possesses and applies a broad knowledge of Quality principles and a document management program. They will process documentation in the Electronic Quality Managements System (eQMS). They will closely work with end users and provide customer service and aid in troubleshooting. Experience in the FDA, CLIA, CAP and/or ISO environment plus demonstrated familiarity with the standard quality and project management concepts is preferred. 

Essential Functions

• Initiating, revising, and processing SOPs, policies and other controlled documents in the eQMS
• Assist end-users in developing documentation and working with end users to confirm accuracy
• Create, manage, and revise user profiles in the eQMS
• Support Quality Management Activities pertaining to the generation of Effectiveness Verification Checks (EVC), Corrective and Preventive Action (CAPA) Plans, and CAPA Tasks
• Support and update QMS related metrics
• Perform, track, and document follow-up activities with QMS record owners (EVCs, CAPA Plans, and CAPA Tasks)
• Coordinate physical document records for offsite storage with various teams
• Other duties as assigned

Qualifications

• Bachelor's degree or equivalent work experience
• 2+ years of experience in a quality/compliance related field or hard-science related industry
• Proficient with MS office programs (Word, Excel, Powerpoint, and Outlook)
• Experience with Tableau
• Strong ability to navigate electronic systems (i.e., Veeva, SalesForce, and internally developed systems)
• Strong analytical, written/verbal communication, interpersonal, and relationship building skills
• 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, critical thinking, and investigative skills

Preferred

• Bachelor's degree in scientific discipline
• Previous experience with Veeva or ComplianceQuest Quality Systems
• Previous experience in a CAP-accredited, CLIA-licensed laboratory

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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 401k, medical, dental, vision, FSA, paid sick leave and generous paid time off (PTO) program. 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 a