Quality Specialist I - Hybrid 2 to 3 days on-site Aliso Viejo CA
Quality Specialist I - Hybrid 2 to 3 days on-site Aliso Viejo CA
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Job Description
Compensation: $27.00 $30.00 per hour. You are eligible for a ShortTerm 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 endusers 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 followup 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
- Bachelors degree or equivalent work experience
- 2 years of experience in a quality/compliance related field or hardscience 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 thirdperson narratives technical summaries and the ability to clearly outline processes/workflows in universally understood language
- Demonstrated problemsolving critical thinking and investigative skills
Preferred
- Bachelors degree in scientific discipline
- Previous experience with Veeva or ComplianceQuest Quality Systems
- Previous experience in a CAPaccredited CLIAlicensed laboratory
#LISS1 #LIHYBRID
About Us:
Ambry Genetics Corporation is a CAPaccredited and CLIAlicensed molecular genetics laboratory based in Aliso Viejo California. We are a geneticsbased 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 cuttingedge 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 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 drugfree work environment.
The Company believes in second chance 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 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 jobrelated 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
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 Ambrys Privacy Notice Click here: review the California privacy notice click here:California Privacy Notice Ambry Genetics
To review the UKG privacy notice click here:California Privacy Notice UKG
Required Experience:
Unclear Seniority
Employment Type
Full-Time
