.Biomat USA, Inc. Quality Systems Associate in Toledo, Ohio 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.
Quality Systems Associate Summary: Under the direct supervision of the Quality Systems Manager, perform quality assurance and training functions to ensure compliance with internal and external regulations and protocol.
Primary Responsibilities: Completes weekly review of equipment QC and maintenance records.
Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they relate to product quality and/or donor safety.
Inspects and releases incoming supplies.
Investigates and reports supplies that have not met quality specifications and requirements prior to use.
Performs documentation review for unsuitable test results.
Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed.
Performs all product release activities.
Reviews lookback information and documentation.
Reviews waste shipment documentation.
Reviews unexpected plasmapheresis events including electronic donor chart and related documentation pertaining to exceptions occurring during the donation process.
Reviews electronic donor chart exceptions impacting donor eligibility/safety and/or product quality.
Reviews donor deferral notifications from competitor centers.
Reviews plasma processing documentation to ensure the proper freezing, storage and handling of product.
Training Responsibilities: Assist the Quality Systems Manager to ensure center training programs follow procedural requirements as defined in the donor center SOP and/or training program documents.
Creates, maintains, and audits training records and files to ensure compliance.
Performs employee training observations to ensure staff competency prior to releasing employees to work independently.
Conducts required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.
On an occasional basis, when the Quality Systems Manager is absent, the Quality Systems Associate may be required to perform the following duties: Reviews and approves of deferred donor reinstatement activities.
Assists with completion of the internal donor center audit.
Additional Responsibilities: Is certified and maintains certification as a Donor Center Technician.
Knowledge, Skills, and Abilities: Developing command of interpersonal communication, organizational and problem-solving skills.
Ability to understand FDA regulations