Quality Assurance Manager

Company: Gift of Life Marrow Registry
Location: Boca Raton
Posted on: May 14, 2022

Job Description:

WE ARE LOOKING FOR QUALIFIED CANDIDATES FOR FL LOCATION ONLY. THIS IS NOT A REMOTE POSITION.

At Gift of Life, we believe every person battling blood cancer deserves a second chance at life - and we are determined to make it happen. We are singularly passionate about engaging the public to help us get everyone involved in curing blood cancer, whether as a donor, a volunteer, or a financial supporter. It all begins with one remarkable person, one life-changing swab, and one huge win - finding a match and a cure.

MISSION
The Gift of Life Marrow Registry cures blood cancer through cellular therapy.

Education
Bachelor's Degree. Certification in Quality Auditing, Lean/Six Sigma, Project Management or equivalents, desirable.

Summary Statement
The Quality Assurance Manager assists the Director, Quality Assurance and Regulatory Compliance with oversight of the Quality Management System, (QA/QC, cGMP, cGTP, and cGLP) ensuring that systems and procedures are compliant with applicable federal and state laws and regulations and accreditation standards.

Responsibilities
Under the guidance and direction of the Director, Quality Assurance and Regulatory Compliance, the Quality Assurance Manager shall:
Assist in promoting and maintaining a quality culture throughout the organization.
Assist with the re-certification activities (AABB, FACT, CLIA), federal registrations, and state licensing applications.
Assist with investigation and resolution of deviations, complaints, and adverse reactions, including root cause analysis, corrective and preventative actions, and effectiveness checks.
Assist in the document review and manufacturing release process for cellular therapy products.
Ensure validation plans exist and are executed according to internal SOPs, as well as external regulations.
Analyze audit outcomes and monitor corrective and preventative actions.
Maintain QA-related documents and reports.
Participate in continual improvement activities to enhance the Quality Management System across all departments (Donor Services, Apheresis Center, Cellular Therapy Laboratory, and Gift of Life Biologics).
Develop a working knowledge of all areas of the organization and a clear understanding of the organization's key functional processes and resources.
Fulfill other duties as assigned.

Knowledge, Skills, and Experience
3-5 years of experience in cGLP, cGMP, and cGTP (i.e. stem cell or bone marrow processing) with 1-3 years of experience specifically in Quality Assurance. At least one year experience or familiarity with US and EU cleanroom regulations.
Working knowledge of AABB standards, FACT Common Standards for Cellular Therapy, 21 CFR 210 & 211, and FDA cGMP and cGTP regulations, and ISO 14644 Cleanrooms and associated controlled environments.
Working knowledge and skills in quality management in the field of cell therapy processing and cryopreservation.
Experience in quality systems in cellular therapy laboratories and manufacturing.
Must be detail-oriented and demonstrate good documentation practices.
Demonstrate ability to manage and prioritize multiple projects and meet deadlines.
Possess strong oral and written customer service and communication skills. Must be able to remain calm and tactful when resolving problems involving all levels of staff, patients, visitors, vendors, etc.
Adept at problem-solving and decision-making.
Flexible and adaptable to changing conditions.
Knowledge of statistical analysis to improve quality.
Good project management skills.
Knowledge, training, and experience in QA principles and data management systems.
Evidence of understanding and monitoring of compliance with SOPs.
Proficient in Microsoft Office Suite and other data management software.
Excellent time management, organizational skills, and ability to set priorities.
Experience interacting with regulatory bodies is a plus.
Demonstrated ability to work independently as well as part of an integrated team.

Physical Demands
This position is basically sedentary with some walking, standing, stooping, and lifting required. -Occasional lifting of objects weighing in excess of 20 pounds. -Travel may also be required.

This job description is not intended to be all-inclusive. -Duties and/or responsibilities may be added or deleted as management requires them to meet the ongoing needs of the organization.

Keywords: Gift of Life Marrow Registry, Boca Raton , Quality Assurance Manager, Executive , Boca Raton, Florida