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Summarize the primary
function of the position:
To support MTF’s
quality system by establishing and maintaining the validation program
in compliance with applicable government regulations and the
standards of the American Association of Tissue Banks, the U.S. Food
and Drug Administration, and other regulatory bodies.
Describe the major
elements of the position in order of importance:
1. Designs,
coordinates, performs, analyzes, reports,
and maintains process validations and equipment qualifications.
This includes but is not limited to writing protocols, overseeing or
performing protocols, and reporting results to management
2. Assists
Quality Assurance, Research & Development, and other departments
with product development studies, validation and other engineering
projects;
3. Works on
interdepartmental teams to develop specification, procedural and
regulatory compliance (cGMP, QSR, GTP, and
AATB Standards, as applicable) of tissue forms and medical devices.
4. Coordinates
special project testing with outside consultants as needed.
Performs analysis of data and reports results to management.
5. Composes and
updates Quality Assurance Standard Operating Procedures,
specifications, and validation procedures. Assists other
departments with procedure controls.
6. Assists in
the identification and development of production controls for new
products.
7. Supports the
regulatory submission process for tissue-based products and medical
devices.
8. Represents
MTF on matters of quality with QA personnel, other departments within
MTF, procurement agencies, and suppliers of goods and services used
in tissue processing and distribution.
9. Assists on
special projects and performs additional duties as assigned.
Job Qualifications
(education, certification, experience, knowledge, skills, physical
requirements)
1. Bachelor’s
degree in science or engineering.
2. Minimum
two years of quality assurance or FDA regulatory experience required;
industry certification extremely helpful (i.e., ASQ-CQA, CQE; CTBS).
3. Excellent
communication, organizational, and technical writing skills.
4. Must be
computer literate, including Microsoft Word and Access, and
statistical software.
Please submit resume and
salary requirements to HRDept4@mtf.org
. Resumes received without
salary requirements will not be reviewed.
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