Random trivia time! Did know that Cincinnati is Steven Spielberg's birthday place? How about they're also the capital of cornhole? I bet you didn't know they are home to America's oldest baseball team. Do you know what else Cincinnati has? Opportunities, duh! If you're a Quality Assurance professional looking to take the next step in your career, you should keep reading!
Lighthouse Lab Services is representing a brand-new, up-and-coming lab that is looking for a Lead Quality Assurance Auditor to join their team! Interested? Then apply, silly beans!
The role you'll play:
You'll be responsible for the assessment of quality and compliance according to CLIA and CAP certifications and requirements, GLP, and Laboratory SOP's.
Duties for this position include, but are not limited to:
-Author, review and maintain as applicable Standard Operating Procedures (SOP) for the laboratory.
-Provide training and guidance regarding quality and regulatory compliance for laboratory staff.
-Participate and support Risk Assessments within the Quality Management System to continuously improve processes.
-Participate in outside qualification aduits for vendors supplying services and products, subcontractors, including contract laboratories, resolve and follow-through on any quality issues.
-Conduct in-study and facility-based audits, including equipment/instrument qualifications, equipment, calibration and maintenance, software validation and laboratory processes in compliance with QAU SOP's,
-Conduct reviews of protocols, final reports and contributing scientists reports, when applicable.
-Effectively report quality issues to supervisor and Laboratory Management, as appropriate.
-Provide input for process investigations, nonconforming quality events, client concerns and the associated CAPA plans.
-Host quality-led sponsor audits
-Host inspections and help ensure the laboratory maintains current federal, state and local licensure and accreditation (as applicable).
-Host and/or support regulatory authority inspections.
-Maintain properly indexed quality assurance records. Assure all QA records are up-to-date and accurate and compile the appropriate records for archiving.
-Attend pre-initiation, pre-planning, or operational team meetings as needed.
-Participate in quality projects as assigned.
-Promote strong relationships with Sponsors.
Basic Preferred Profile:
-Bachelors in Clinical Laboratory Science, Biology, Chemistry or similar.
-5+ years of quality assurance experience in a clinical laboratory setting.
-Must have a working knowledge of State, CAP, and CLIA standards and be familiar with licensing requirements.
-Experience with instrument/equipment qualification, calibration, and software validation.
-Working knowledge of quality assurance GLP, GCP, and GLP best practices.
-Knowledge of electronic data collection systems used in data generation, including proper use, reporting, audit trails, security/Part 11 compliance, data correction, QC. etc.
Salary and Benefits:
-Competitive Salary, based on experience.
-Full Benefits, along with 401K included.
-Relocation Assistance provided.
Like what you read above? Then what are you waiting for?! APPLY!
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: 13455