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Quality Assurance Specialist

Company: Aerotek
Location: Boca Raton
Posted on: May 2, 2021

Job Description:

Description:Summary StatementThe Quality Assurance Specialist assists the Director, Quality Assurance and RegulatoryCompliance with oversight of the Quality Management System (QA/QC, cGMP, cGTP, andcGLP) ensuring that systems and procedures are compliant with applicable federal andstate laws and regulations and accreditation standards.Responsibilities. Assist in promoting and maintaining a quality culture throughout the organization.. Assist with the re-certification activities (AABB, FACT, CLIA), federal registrations andstate licensing applications.. Assist with investigation and resolution of deviations, complaints, and adversereactions, including root cause analysis, corrective and preventative actions andeffectiveness checks.. Assist in the document review and manufacturing release process for cellulartherapy products.. Ensure validation plans exist and are executed according to internal SOPs, as well asexternal regulations.. Analyze audit outcomes and monitor corrective and preventative actions.. Maintain QA-related documents and reports.. Participate in continual improvement activities to enhance the QualityManagement System across all departments.Knowledge, Skills, and Experience. 3-5 years of experience in cGLP, cGMP, and cGTP (i.e., stem cell or bone marrowprocessing) with 1-3 years of experience, specifically in Quality Assurance.. Working knowledge of AABB standards, FACT Common Standards for CellularTherapy, 21 CFR 210 & 211, and FDA cGMP and cGTP regulations.. Working knowledge and skills in quality management in the field of cell therapyprocessing and cryopreservation.. Experience in quality systems in cellular therapy laboratories and manufacturing. About Aerotek: We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing-- Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Boca Raton , Quality Assurance Specialist, Other , Boca Raton, Florida

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