Quality Systems Manager for Plasma Center
Company: GRIFOLS, S.A.
Posted on: September 14, 2023
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.
Job Title: QUALITY SYSTEMS MANAGER
Evaluates processes, develops action plans, and coordinates the
strategic implementation of system processes and corrective
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 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
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.
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
- Builds rapport with donors to ensure overall customer
satisfaction with the Center to support long-term donation.
- Reviews and approves of deferred donor reinstatement
- 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.
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.
- 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.
- Typically requires 2-5 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.
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
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
We provide a comprehensive package of benefits including medical,
pharmacy, dental, vision, disability insurance, life & AD+D
insurance, Paid Time Off (PTO), 5% 401K match, and tuition
reimbursement. We are committed to offering our employees
opportunities for professional growth and career progression. In
this role, you will also be eligible to participate in the
company's bonus program.
#BiomatUSA #CB #GrifolsJobs
Grifols is an Equal Opportunity Employer:
"We are looking to grow our teams with people who share our energy
and enthusiasm for creating the best experience for our
Location: NORTH AMERICA : USA : KS-Topeka
Address: 2915 SW Gage Blvd, Topeka, KS 66614
Center Facebook Page: https://www.facebook.com/BiomatTopekaGage
Contact: Alex S. Contreras, HR Staffing Partner III - (323)
Learn more about Grifols
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To find more jobs with Grifols: https://grifols.jobs
Keywords: GRIFOLS, S.A., Topeka , Quality Systems Manager for Plasma Center, Executive , Topeka, Kansas
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