Quality Systems Associate

Grifols•Monroe, LA

11d•Onsite

About The Position

This position performs quality assurance and training activities in a Whole Blood center in accordance with Standard Operating Procedures (SOPs). It supports center compliance, product quality, donor suitability, and donor safety through record review, employee-practice monitoring, process assessment, corrective and preventive action evaluation, and escalation of quality concerns to management and Corporate Quality Assurance. The role also coordinates, implements, and monitors training initiatives for Whole Blood center personnel. The position independently inspects and controls quality processes, interprets and implements applicable regulations and SOPs, and collaborates with the Center Manager and Regional Quality Manager on audits, corrective and preventive actions, quality-system improvement, and regulatory compliance. It oversees training-monitor personnel, product and biohazard waste shipments, donor and test-result records, supply quality, equipment maintenance and calibration, and documentation. The role investigates deviations and customer complaints, analyzes trends and root causes, prepares quality reports, and supports donor suitability and donor reinstatement decisions. Work is performed in an office and/or laboratory/manufacturing environment, with exposure to biological fluids, potential infectious organisms, office equipment, production chemicals, moving machinery, and high noise levels. Protective eyewear, garments, and gloves are required. The role involves occasional travel within the United States and the ability to work independently while communicating and collaborating with diverse groups.

Requirements

Typically requires 2 years of related experience in a medical and/or cGMP-regulated environment.
Strong 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 and legible handwriting.
High proficiency with computers.
Proficiency in root-cause analysis and corrective/preventive actions.
Ability to balance competing priorities and manage time effectively.
Ability to maintain high standards of quality and compliance and contribute to the center leadership team.
Ability to work with minimal supervision and little guidance.
Ability to communicate complex information, listen and understand spoken information, and work with diverse groups to reach consensus.
Ability to apply abstract principles to complex conceptual issues.
Bachelor of Arts or Bachelor of Science degree preferred.
Certified and proficient as a Designated Trainer, or committed to completing a certification program as a reimbursable educational expense under the Grifols Tuition Reimbursement policy.

Nice To Haves

Experience with plasma or whole blood collections.
Experience working with adult learners or in adult education programs.
Bachelor of Arts or Bachelor of Science degree.

Responsibilities

Ensure center compliance with quality standards and regulations in collaboration with the Center Manager and Regional Quality Manager, supporting product quality, donor suitability, and donor safety.
Direct and monitor processes to ensure compliance with applicable state, federal, and company-designated regulations and that SOPs are interpreted and implemented appropriately.
Interpret and implement quality-control processes, regulations, and SOPs, making independent decisions and modifications as required.
Coordinate oversight of internal and external audits, including documentation, review and preparation of responses, corrective and preventive action implementation, effectiveness assessment, and follow-up.
Assess and improve the effectiveness of donor-center quality systems by identifying trends, investigating procedural failures, observing employees, and reviewing center documents.
Direct, assign work to, develop, and train Training Monitor personnel.
Oversee product and biohazard waste shipments, ensuring regulatory specifications, product-release requirements, accurate labeling and documentation, and authorizing final shipment.
Review test results and verify that unsuitable donors are properly documented.
Work with the Center Manager to develop staff knowledge of job functions and how performance relates to the end product and patient.
Document and investigate deviations and customer complaints, perform root-cause analysis, and address donor safety and product quality concerns.
Track and trend center quality incidents, follow up on incidents and errors, report critical incidents and problematic trends to the Center Manager, and report compliance status to necessary parties.
Review SOPs with trainees and perform job skills during training; monitor training documents and ensure job and cGMP training is completed, documented, and on file.
Ensure donor files are accurate and review deferred-donor reinstatement activities, lookback information, medical incident reports, and related documentation.
Verify that supplies and materials meet quality requirements and are stored appropriately; initiate investigations when requirements are not met and reject nonconforming supplies.
Direct equipment maintenance and calibration and documentation of procedures.
Track, trend, and follow up on corrective and preventive actions, system implementations, and process-improvement plans; assess effectiveness and make adjustments as required.
Ensure required QC checks are performed and test-reagent results are within acceptable ranges.
Direct routine verification of SOPs and forms to ensure donor-center manuals are up to date.
Partner with the Center Manager to determine donor-suitability activities and manage donor deferrals as appropriate.
Prepare quality-analysis reports to track issues and set goals, and research and analyze systemic compliance issues.
Build rapport with donors to support customer satisfaction and long-term donation.
Travel as needed for meetings, events, and occasional support of other centers.