When you think of Miami, what comes to mind? Is it the miles of gorgeous beaches? Maybe Art Deco Distract is more your style? How about the Bayside Market? If none of those things catch your eye, how about new opportunities? If that made you excited, you should keep reading!
Lighthouse Lab Services is representing a reference lab in Miami that is looking for Quality Assurance Director to join their team! This is a fantastic opportunity for someone who wants to take the next step in their careers.
Key responsibilities for this position include, but are not limited to:
-Oversees Quality Management System in accordance with ISO 9001:2015 Standard; strong understanding of cGMP working environments and a strong understanding of reading and interpreting FDA CFR.
-Knowledge of 21 CFR 640 is highly beneficial.
-Ensure audits, internal reviews, creation/editing/publishing of SOP’s, document review and validations are executed in a timely, reasonable and accurate way.
-Maintains the Calibration database; issues calibration due notifications.
-Create and submit annual FDA Report and site registrations.
-Lead FDA, ISO and Customer Audits. Liase with the Medical Director and Lab Supervisor to co-lead COLA/CLIA audits.
-Ensures all Regulatory Requirements are met; newly issued FDA, ISO & CLIA requirements should be monitored and management made aware.
-Maintain and perform internal Audit Schedule, and manage CAPA response.
-Control SOP and all quality documents through the document control system.
-Design training and train personnel in QA areas, as appropriate.
-Liaise with the Medical Director Laboratory Supervisor and plasma physician.
Basic Preferred Profile:
-Bachelor's in Chemistry, Physical, Biological Sciences or equivalent required.
-5+ of Quality Assurance Management experience required.
-Previous experience with ISO 9001 required.
-Previous experience with FDA Audits required.
-Previous experience working with CLIA/COLA considered an added plus.
Salary and Benefits:
-$85,000-98,000, depending on experience
-Health, Vision, and Dental benefits after 90 days
-401K available after employment of one year.
-Relocation on a case-by-case basis.
If you fit the above profile, we'd love to hear from you!
At Lighthouse Lab Services, we offer solutions to help start, grow, and run clinical laboratories. Our recruiting team has over 17 years of proven success placing job seekers in positions ranging from entry-level Medical Technologists to seasoned Laboratory Directors. We recruit nationwide, for permanent and travel positions with clients ranging from small hospitals to large reference laboratories.
It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Lighthouse Lab Services will provide reasonable accommodations for qualified individuals with disabilities.
Lighthouse Lab Services | 800-838-0602 | lighthouselabservices.com
#MP Job ID: 12356