Quality Systems Manager
Company: Grifols
Location: Cranston
Posted on: November 13, 2024
Job Description:
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Would you like to join an international team working to improve the
future of healthcare? Do you want to enhance the lives of millions
of people? Grifols is a global healthcare company that since 1909
has been working to improve the health and well-being of people
around the world. We are leaders in plasma-derived medicines and
transfusion medicine and develop, produce and market innovative
medicines, solutions and services in more than 110 countries and
regions.
Primary Responsibilities for role: - - - - - - - - - - - - - - - -
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- Maintains oversight of the center's quality management system
and ensures continuous quality improvement, by addressing
deficiencies in a timely manner and communicating concerns to the
appropriate parties. - - - - - - - - - - - - - - - - - - - - - - -
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- Directs and monitors processes and ensures center compliance
with all applicable state, federal, and company-designated
regulations. Implements Standard Operating Procedures (SOPs) for
quality control and overall regulatory compliance. - - - - - - - -
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- Maintains oversight of center training program by ensuring
compliance to program requirements promoting staff competency in
their assigned job duties. Maintains and audits training records
and files. - - - - - - - - - - - - - - - - - - - - - - - - - - - -
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- Collaborates with Center Manager to ensure the donor center
operates in a manner which assures product quality, donor
suitability and donor safety are maintained. - - - - - - - - - - -
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- Responsible for the personnel functions of the Quality
Associate; including direction, assignment of work, hiring,
development and training, disciplinary actions, termination,
maintenance of personnel records, work schedule and
delegation/follow-up of tasks. - - - - - - - - - - - - -
- Responsible for oversight of all aspects of internal and
external audits including audit preparation, execution, response,
implementation of corrective/preventative actions, assessment of
corrective actions, and follow-up as required. - - - - - - - - - -
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- Continuously assesses, promotes, and improves the effectiveness
of quality and training systems in the donor center through
recognition of trends, investigation of failures in the execution
of procedures, and direct observations. - - - - - - - - - - - - - -
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- 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. - - - -
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- Investigates identified trends and performs follow-up on
corrective and preventative actions, system implementations, and
process improvement plans to measure/determine effectiveness. - - -
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- Oversees product and biohazard waste shipments: - Ensures
shipments meet regulatory specifications and product release
requirements; ensures accurate labeling and documentation; and,
authorizes final shipment. - - - - - - - - - - - - - - - - - - - -
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- Performs a review of the documentation of unsuitable test
results and unit lookback information.
- Performs a review of donor adverse event reports and the
applicable related documentation.
- Ensures that job and center annual training (i.e. Advanced
cGMP, Blood Borne Pathogen, and others as required) is completed,
documented, and on file. - - - - - - - - - - - - - - - - - - - - -
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- Performs employee training observations to ensure staff
competency prior to releasing employees to work independently. - -
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- Ensures that all supplies and materials ordered meet quality
requirements prior to use and are always stored in appropriate
temperature/facility conditions. Initiates appropriate
investigations if these requirements are not met. Initiates
rejection of supplies for non-conformance. - - - - - - - -
- Determines donor suitability activities and manages donor
deferrals as appropriate. Reviews and approves of deferred donor
reinstatement activities. - - - - - - - - - - - - - - - - - - - - -
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- Prepares quality analysis reports to track issues and set
goals. Does in depth research and analysis to resolve systemic
compliance issues - - - - - - - - - - - - - - - - - - - - - - - - -
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- Ensures that Clinical Laboratory Improvement Amendments (CLIA)
proficiency test surveys, complaint investigations, and training
have been properly documented. - - - - - - - - - - - - - - - - - -
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- Holds monthly Quality Meeting to communicate status updates and
manage action outcomes. - - - - - - - - - - - - - - - - - - - - - -
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EDUCATION AND EXPERIENCE - -
- Bachelor of Science degree or equivalent. -
- Typically requires 2 years of related experience in a medical
and/or cGMP regulated environment. Experience with plasma or whole
blood.
- Depending on the area of assignment, directly related
experience or a combination of directly related education and
experience and/or competencies may be considered in place of the
stated requirements. - Example: - If a job level requires a
Bachelor's degree plus 4 years of experience, an equivalency could
include 8 years of experience, an Associate's degree with 6 years
of experience, or a Master's degree with 2 years of experience.
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KNOWLEDGE, SKILLS & ABILITIES
Command of interpersonal communication, organizational and
problem-solving abilities. - Ability to understand and assess FDA
regulations. - Strong integrity and commitment to quality and
compliance. - Full command of mathematics. - Legible handwriting. -
High level of proficiency with computers. - Proficient in root
cause analysis and corrective/preventative actions. - Ability to
balance multiple competing priorities. - Strong time management
abilities. - Proven ability to maintain a high level of quality and
compliance and to become a valuable member of the center leadership
team. - Ability to work with minimal supervision. - Ability to
travel when needed for meetings, events, and occasional support of
other centers.
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OCCUPATIONAL DEMANDS
Occupational Demands Form # 6: - Work is performed in an office
and/or a laboratory/manufacturing environment. Exposure to
biological fluids with potential exposure to infectious organisms.
- - Exposure to electrical office equipment. Exposure to extreme
cold below 32*, miscellaneous production chemicals, moving
machinery and production equipment. Exposure to high levels of
noise on production floor. - Personal protective equipment required
such as protective eyewear, garments and gloves. - Frequently sits
for 6-8 hours per day. Repetitive hand movement of both hands with
the ability to make fast, simple, repeated movements of the
fingers, hands, and wrists. - - Occasionally walks. Occasionally
bends and twists neck. Light to moderate lifting and carrying
objects with a maximum lift of 35lbs. Frequently drives to site
locations with occasional travel within the United States. Able to
communicate complex information and ideas so others will
understand; with the ability to listen to and understand
information and ideas presented through spoken words and
sentences.
Works independently with little guidance or reliance on oral or
written instructions and plans work schedules to meet goals.
Frequently interacts with others, relates sensitive information to
diverse groups. Must work with diverse groups to obtain consensus
on issues.
Ability to apply abstract principles to solve complex conceptual
issues.
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We offer benefits including medical, PTO, up to 5% 401K match, and
tuition reimbursement. We are committed to offering our employees
opportunities for professional growth and career progression. Even
though we are a global healthcare company with employees in 30
countries, Grifols prides itself on its family-like culture. Our
company has more than tripled its workforce in the last 10 years -
we're growing, and you can grow with us!
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#biomatusa
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#app
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#LI-CM1
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Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active,
nonexpired, Grifols Agency Master Services Agreement with the
Grifols Talent Acquisition Department. Additionally, agencies may
only submit candidates to positions that they have been engaged to
work on by a Grifols Recruiter. All resumes must be sent to a
Grifols Recruiter under these terms or they will be considered a
Grifols candidate.
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Grifols provides equal employment opportunities to applicants and
employees without regard to race, color, religion, sex, sexual
orientation, gender identity, national origin, protected veteran
status, disability or any other characteristic or status protected
by law. We will consider for employment all qualified Applicants in
a manner consistent with the requirements of applicable state and
local laws
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Location: -NORTH AMERICA : USA : RI-Cranston:USCRN - Cranston
RI-Garfield Ave-BIO -
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Keywords: Grifols, Brookline , Quality Systems Manager, Executive , Cranston, Massachusetts
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