3 Quality Assurance Specialist II (Hybrid/Onsite-Aliso Viejo, CA) Jobs in Aliso Viejo, CA
Ambry Genetics is Hiring a Quality Assurance Specialist II (Hybrid/Onsite-Aliso Viejo, CA) Near Aliso Viejo, CA
Quality Assurance Specialist II (Hybrid/Onsite-Aliso Viejo, CA)Minimum of 2 days on siteJob Overview:The Quality Assurance Specialist II is responsible and accountable for quality tasks and operations. Works directly with clinical laboratory, bioinformatics and reporting managers to support Quality Management Program activities and the generation, collation and reporting of key quality and performance metrics across the preanalytical, analytical and postanalytical testing phases. Schedule, plan and conduct internal audits in accordance with the annual audit schedule. Support the maintenance and execution of Quality Management Systems and provide Electronic Document Management System (EDMS) support. Quality Assurance Specialist II must possess and apply a broad knowledge of Quality practices within the clinical laboratory environment (molecular genetics). Experience preferred in CLIA, CAP and/or ISO and FDA regulatory bodies
Essential Functions:
- Must demonstrate effective decision-making, teamwork and collaboration to ensure effective communication among all department stakeholders on R&D and clinical projects as well as within quality and regulatory leadership.
- Gather and collate data in preparation for monthly and quarterly Quality Management Review to identify trends.
- Manage, plan, schedule and conduct the quarterly Quality Management Review meetings to ensure laboratory directors actively review and evaluate established key quality and performance measures.
- Maintain and execute Internal Auditing, Quality Event Reports, Corrective/Preventive Actions, Complaint Handling and supplier/vendor management programs to ensure prompt documentation. Provides guidance on resolutions as well as adequate Quality metrics tracking, trending, monitoring and reporting.
- Track audit responses and any resulting CAPA until resolution and closeout.
- Supports Quality team during regulatory inspections.
- Own, write, revise, review and approve controlled documents and provide valuable input for continuous process improvements to ensure compliance with regulations and current industry standards.
- Supports the maintenance and execute support for EDMS/PolicyTech by assisting with reviews and approvals of quality systems reports, validation records and training materials.
- Demonstrate teamwork and collaboration to ensure effective communication among all departments.
- Other duties as assigned
- Bachelor degree in a hard-science
- Proficient with MS office programs (Word, Excel, Powerpoint, Visio and Outlook)
- Strong analytical, written/verbal communication, interpersonal, and relationship building skills
- Ability to work independently and multi-task, with strong decision making skills
- 5 years of experience in a quality/compliance related field or hard-science related industry.
- Preferred auditing certification, such as ASQ, CQA.
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.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 GeneticsTo review the UKG privacy notice, click here: California Privacy Notice | UKG
Job Summary
Full Time
$82k-101k (estimate)
06/08/2024
07/06/2024
ambrygen.com
Aliso Viejo, CA
500 - 1,000
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