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Center Quality Manager

Location: 

GA-Columbus, US

Contract Type:  Regular Full-Time
Area:  Quality
Req Id:  137177

For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.

Headquartered in Barcelona, Spain, Grifols has over 20.000 employees in 30 countries. Grifols’ three main divisions - Bioscience, Diagnostic and Hospital - develop, manufacture and market innovative products and services available in more than 100 countries.

With the world's largest network of plasma donation centers, Grifols, through its Bioscience Division, is a leading producer of essential plasma-derived medicines for the treatment of rare, chronic, and sometimes life-threatening conditions. To help ensure a reliable and consistent source of plasmaderived medicines worldwide, we have an integrated production process that begins with plasma collection and continues through fractionation and purification at our three facilities located in Spain (Barcelona) and the United States (Clayton, North Carolina, and Los Angeles, California). Key products include immunoglobulins, alpha-1 antitrypsin, albumin, clotting factors and specialty products.

Center Quality Manager

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 including 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 Assoc(s); including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of all

● 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.

● 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.

● 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.

● Directs the maintenance and calibration of equipment and documentation of procedures.

● Ensures that Clinical Lab 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.

● 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.

Job Requirments:

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. Certification as a Designated Trainer for quality area is required.

Location: NORTH AMERICA : USA : GA-Columbus:USNC0504 - Columbus GA-Victory Dr-TPR 

 

Learn more about Grifols