Quality Assurance Specialist II (Document Control) – Hybrid, Aliso Viejo, CA (preferred) or REMOTE: USA

Description :
Compensation: $75,000 – $85,000 per year. 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 II (Document Control) – Hybrid, Aliso Viejo, CA (preferred), but will consider REMOTE: USA
Job Overview:
The Quality Assurance Specialist II is responsible and accountable for quality tasks and operations. Possesses and applies a broad knowledge of Quality principles and a document management program. Develop, execute implementation and manage the Electronic Document Management System (EDMS), PolicyTech, and Back-up for Learning Management System (LMS). Develop and implement EDMS training, provide customer service and aid in troubleshooting EMDS. Work collaboratively cross-functionally. Experience in the FDA, CLIA, CAP and/or ISO environment plus demonstrated familiarity with the standard quality and project management concepts.
Essential Functions:
Must demonstrate Quality-related decision making, teamwork and collaboration to ensure effective communication among all department stakeholders on R&D and clinical projects.
Execute the implementation of the new electronic document management system (EDMS) for all controlled documents and controlled records supporting clinical laboratory operations and their applicable regulation and standard practices.
Provide EDMS customer service company-wide and aid in system troubleshooting with EDMS vendor and IT Security, when requested
Develop and conduct EDMS training to ensure all employees have access and can navigate within the system.
Track and trend document control metrics while driving overall performance, improvement and reduction of document review through approval turnaround time and company-wide compliance.
Coordinate the execution of special projects documentation with the Program Manager, quality and regulatory management and departmental management.
Develop records control practices and manage the electronic archival.
Support Quality Assurance controlled documents and controlled records activities including change control, CAPA, quality metrics monitoring, internal auditing, and database management, when needed
Support Regulatory Affairs with accrediting body, state, federal and local licensing and permit processing. Assist with regulatory agencies during inspections and audits.
Support Environmental, Health and Safety training materials and routine safety records.
Demonstrate teamwork and collaboration to ensure effective communication among all departments. * Other duties as assigned
Qualifications:

Bachelor of Science, or equivalent 8-years of industry experience

Min of 1 year of experience contributing to laboratory, pharmaceutical, or biotechnology company or related business.

Experience training personnel, workflow processes and successful track record of keeping up with their own competencies.

Proficient with MS office programs (Word, Excel, Powerpoint, Visio, Projects) and Outlook

Ability to work independently and multi-task, with strong decision making skills

Excellent customer and service focus

Excellent written, verbal, and interpersonal communication skills.

Demonstrated success working with a team and on projects

Demonstrated knowledge of operational/logistical aspects of clinical testing as well as regulatory requirements; FDA, CAP, CLIA and ISO regulations.

Strong understanding of FDA/ICH and the clinical trials process.

Preferred:

PMP and Six Sigma Certification preferred

Min. 1 year of experience with Veeva Vault (EDMS), Training Vault (LMS) is 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 . 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
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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Ambry Genetics