Quality Assurance Manager
Company: Gift of Life Marrow Registry
Location: Boca Raton
Posted on: June 25, 2022
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.MISSIONThe 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 StatementThe 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.ResponsibilitiesUnder 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
- 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
- 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
- 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
- Working knowledge and skills in quality management in the field
of cell therapy processing and cryopreservation. -
- Experience in quality systems in cellular therapy laboratories
- Must be detail-oriented and demonstrate good documentation
- 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
- Evidence of understanding and monitoring of compliance with
- Proficient in Microsoft Office Suite and other data management
- 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 DemandsThis 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
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