Center Quality Manager
Company: Grifols Inc.
Posted on: August 2, 2022
Do you want to join an international team working to improve the
future of healthcare? Do you want to improve the lives of millions
of people? Grifols is a global healthcare company which, since its
foundation in Barcelona in 1909, has been working to improve the
health and well-being of people all over the world. Our four
divisions - Bioscience, Diagnostic, Hospital and Bio Supplies -
develop, produce and market innovative medicines, solutions and
services in more than 100 countries and regions.
Center Quality Manager
Primary Responsibilities for role:
Independent level of quality inspection and control -- ensures
center compliance with quality standards and regulations.
Collaborates with Center Managers to ensure product quality, donor
suitability and donor safety.
Directs and monitors processes and ensures center compliance with
all applicable state, federal, and company-designated
Ensures that Standard Operating Procedures (SOPs) are properly
interpreted, implemented in a timely fashion, and that the staff
performs according to all SOPs.
Interprets and implements processes, regulations and SOPs for
quality control and overall regulatory compliance, making
independent decisions and modifications as required.
Oversight of all aspects of internal and external audits including
execution (if applicable). This includes documentation, review of
and preparation of the response.
Also including implementation of corrective and preventative
action, assessment of corrective and preventative actions and
follow-up as required.
Continuously assesses, promotes, and improves the effectiveness of
the quality systems in the donor center through recognition of
trends, investigation of failures in the execution of
direct employee observation and review of center documents.
Responsible for the personnel functions of the Quality Assoc(s);
including direction, assignment of work, hiring, development and
training, disciplinary actions, termination, maintenance of all
Oversees product and biohazard waste shipments: Ensures shipments
meet regulatory specifications and product release requirements;
ensures accurate labeling and documentation; and, authorizes final
Performs a review of the documentation of unsuitable test results
and the disposition of the associated results.
Documents, investigates, and performs root cause analysis for
deviations and customer complaints, specifically in how they relate
to the safety of the donor and the quality of the product.
Documents and tracks/trends center quality incidents and follows-up
on incidents/errors as required; reports critical incidents and
problematic trends to Center Manager.
Reports compliance status to necessary parties.
Ensures accuracy of donor files.
Directs the maintenance and calibration of equipment and
documentation of procedures.
Ensures that Clinical Lab Improvement Amendments (CLIA) proficiency
test surveys, complaint investigations, and training have been
Monitors training documents to ensure compliance with all
applicable policies and procedures.
Ensures that job and Current Good Manufacturing Practice (cGMP)
training is completed, documented, and on file.
Ensures that quality control (QC) checks are performed as required
and are in acceptable ranges for test reagents.
QM directs routine verification of the SOP and forms to ensure that
they are up to date in the Donor Center's manual.
Partners with the Center Manager to determine donor suitability
activities and manages donor deferrals as appropriate.
Prepares quality analysis reports to track issues and set goals.
Does in depth research and analysis to resolve systemic compliance
Builds rapport with donors to ensure overall customer satisfaction
with the Center to support long-term donation.
Bachelor of Science degree or equivalent. Certified and proficient
in quality and compliance. Works toward certification from American
Society for Quality to be a Certified Quality Auditor.
Certification as a Designated Trainer for quality area is
Location: NORTH AMERICA : USA : CT-Stamford:USSTAMF - Stamford
Keywords: Grifols Inc., Stamford , Center Quality Manager, Executive , Stamford, Connecticut
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