Quality Systems Manager for Plasma Center
Company: Grifols
Location: Kennewick
Posted on: April 13, 2025
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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.
We're Grifols, an international plasma manufacturer headquartered
in Barcelona, Spain. - We serve healthcare professionals and
patients in over 100 countries, have an unmatched record of product
quality and safety, and are the largest plasmapheresis company in
the world.
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If you enjoy working in an environment built around teamwork and
trust, then consider furthering your career with us as a QUALITY
SYSTEMS MANAGER! - Please read on ... -
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JOB TITLE: QUALITY SYSTEMS MANAGER
ESTIMATED SALARY RANGE: - -$68.5K - $103K per year, -depending on
training, education, and experience. - This position is eligible to
participate in up to -20% -of the company bonus pool.
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Summary:
Evaluates processes, develops action plans, and coordinates the
strategic implementation of system processes and corrective
actions.
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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
regulations.
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 includes 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 procedures,
direct employee observation and review of center documents.
Responsible for the personnel functions of the Quality Systems
Associate(s); including direction, assignment of work, hiring,
development and training, disciplinary actions, termination,
maintenance of all personnel records, management of work schedule
and delegation/follow-up of tasks.
Oversees product and biohazard waste shipments: Ensures shipments
meet regulatory specifications and product release requirements;
ensures accurate labeling and documentation; and, authorizes final
shipment.
Performs a review of the documentation of unsuitable test results
and the disposition of the associated results.
Works in collaboration with the Center Manager to develop the
staff's knowledge of their job function and how their performance
relates to the end product and patient.
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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Other Responsibilities for Role: -
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.
Ensures that all supplies and materials ordered meet quality
requirements prior to use and are stored in appropriate
temperature/facility conditions at all times. - Initiates
appropriate investigations if these requirements are not met. -
Initiates rejection of supplies for non-conformance.
Directs the maintenance and calibration of equipment and
documentation of procedures. -
Ensures that Clinical Laboratory Improvement Amendments (CLIA)
proficiency test surveys, complaint investigations, and training
have been properly documented.
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.
Tracks/Trends and performs follow-up on corrective and preventative
actions, system implementations, and process improvement plans to
measure/determine effectiveness. - Makes adjustments where
required.
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
issues.
Builds rapport with donors to ensure overall customer satisfaction
with the Center to support long-term donation. - -
Reviews and approves of deferred donor reinstatement
activities.
Performs a review of lookback information.
Performs a review of medical incident reports and the applicable
related documentation.
Leads projects and initiatives for the region and division.
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This job description is intended to present the general content and
requirements for the performance of this job. - The description is
not to be construed as an exhaustive statement of duties,
responsibilities, or requirements. - Managers and supervisors may
assign other duties as needed.
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Job Requirements:
EDUCATION:
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.
Works toward certification as a Designated Trainer for quality area
is required.
EXPERIENCE:
Typically requires 2-5 years of related WORK experience in a
medical and/or cGMP regulated environment.
Experience with plasma or whole blood.
EQUIVALENCY:
Depending on the area of assignment, directly related work
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 work experience, an associate degree with 6
years of work experience, or a master's degree with 2 years of work
experience.
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.
OCCUPATIONAL DEMANDS: -
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. -
BENEFITS:
We offer a comprehensive package of benefits including medical,
Paid Time Off (PTO), pharmacy, dental, vision, disability
insurance, life & AD+D insurance, 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
#CB
#GrifolsJobs -
#Plasma -
#app
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"We are looking to grow our teams with people who share our energy
and enthusiasm for creating the best experience for our
donors/customers." - -
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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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EEO: -
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,
including those with criminal histories, in a manner consistent
with the requirements of applicable state and local laws, including
the City of Los Angeles' Fair Chance Initiative for Hiring
Ordinance.
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Location: -NORTH AMERICA : USA : WA-Kennewick
Center Address: -101 N Union St, Ste 108, Kennewick, WA 99336 - - -
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Contact: Alex S. Contreras, Staffing Partner III - (213) 219-5494 -
acontreras@grifols.com -
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To find more jobs with Grifols: - -
Or Text GRIFOLS to 833-233-7621
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Keywords: Grifols, Kennewick , Quality Systems Manager for Plasma Center, Executive , Kennewick, Washington
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