Quality Systems Manager

Quality Systems Manager (QSM)

PRIMARY RESPONSIBILITIES:

Evaluates processes develops action plans and coordinates the strategic implementation of quality system processes and corrective actions at the plasma donor center.

Maintains oversight of the centers quality management system and ensures continuous quality improvement by addressing deficiencies in a timely manner and communicating concerns to the appropriate parties.

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.

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.

Collaborates with Center Manager to ensure the donor center operates in a manner which assures product quality donor suitability and donor safety are maintained.

Responsible for the personnel functions of the Quality Systems 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.

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.

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.

Investigates identified trends and performs follow-up on corrective and preventative actions system implementations and process improvement plans to measure/determine effectiveness.

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 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.

Performs employee training observations to ensure staff competency prior to releasing employees to work independently.

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.

Prepares quality analysis reports to track issues and set goals. Does in depth research and analysis to resolve systemic compliance issues

Ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys complaint investigations and training have been properly documented.

Holds monthly Quality Meeting to communicate status updates and manage action outcomes.

JOB REQUIREMENTS:

Bachelor of Science degree or equivalent.

• • Equivalency: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 :If a job level requires a bachelors degree plus 4 years of experience an equivalency could include 8 years of experience an associate degree with 6 years of experience or a masters degree with 2 years of experience.

Typically requires 2 years of related experience in a medical and/or cGMP regulated with plasma or whole blood preferred.

KNOWLEDGE SKILLS AND ABILITIES:

Command of interpersonal communication organizational and problem-solving to understand and assess FDA integrity and commitment to quality and command of level of proficiency with in root cause analysis and corrective/preventative to balance multiple competing time management ability to maintain a high level of quality and compliance and to become a valuable member of the center leadership to work with minimal to travel when needed for meetings events and occasional support of other centers.

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 to electrical office equipment. Exposure to extreme cold below 32 degrees F miscellaneous production chemicals moving machinery and production equipment. Exposure to high levels of noise on production protective equipment required such as protective eyewear garments and 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 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 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 were growing and you can grow with us!

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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.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy childbirth or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.

Location:NORTH AMERICA : USA : SC-Sumter:USSUMT - Sumter SC-S Pike

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