Quality Systems Associate

Grifols • Saint Louis, MO

100d

About The Position

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. The Quality Systems Associate will perform quality assurance and training functions to ensure compliance with internal and external regulations and protocol under the direct supervision of the Quality Systems Manager.

Requirements

• High school diploma or GED.
• Developing command of interpersonal communication, organizational and problem-solving skills.
• Ability to understand FDA regulations.
• Strong integrity and commitment to quality and compliance.
• Good knowledge of mathematics.
• Legible handwriting.
• Proficiency with computers.
• Ability to work flexible scheduling to meet business needs.
• Ability to understand and follow SOP's and protocols.
• Basic understanding of cGMP and quality systems.
• Ability to perform primary responsibilities of the Quality Associate role in a proficient manner.

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, investigating and reporting 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.
• 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.
• Reviews and approves deferred donor reinstatement activities when the Quality Systems Manager is absent.
• Assists with completion of the internal donor center audit.
• Performs review of monthly trending report.
• Performs review of donor adverse events reports and the applicable related documentation.
• Conducts training to address donor center corrective and preventative measures.

What This Job Offers

• Industry: Chemical Manufacturing
• Education Level: High school or GED