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

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