Ambry Genetics is a biotech company which performs clinical genetic testing and contract testing for pharmaceutical and biotech companies. We are seeking a Quality Assurance Specialist experienced with Good Laboratory Practices (GLP) who can assist with the Quality Assurance and regulatory activities of our Quality Department. Ambry Genetics offers a competitive benefits package and a friendly, open and fast paced environment.​ 

Job Description

• Assist the Quality Systems Manager with the GLP, CLIA, and CAP regulatory requirements.
• Responsible for writing, and revising Standard Operating Procedures and implementing a document management system.
• Participates in internal GLP audits by reviewing protocols, study reports, and ensures that all procedures were performed in accordance with the GLP guidelines.
• Assists in the coordination and execution of audits from outside parties.
• Acts as a scribe for external audits and internal laboratory and operations meetings.
• Tracks deviation reports and the resulting corrective and preventative actions.
• Assists with the Proficiency Testing programs to ensure assay accuracy, precision and corrective action.​

Job Requirements:

• BS/​BA degree in laboratory science or other related field.​
• Knowledge of FDA and GLP standards and regulations is required; knowledge of CLIA and CAP standards and regulations is a plus.
• Minimum of 2 years experience in Quality Assurance and Regulatory Affairs or a similar environment.​
• Great documentation practices and strong writing skills in protocols and reports
• Strong interpersonal skills and ability to work as a team player.
• Strong knowledge of computers and software programs including Word, Excel, LIMS, and document management programs.

To Apply

For immediate consideration for this position, please submit your resume and salary history.​