Quality Systems & Training Specialist

Grifols, S.A; Inkster (MI); On-site; USD 52,000 - 76,000; Full time

Job summary

Grifols is seeking a Quality Systems Associate in Inkster, MI, to support quality assurance, training, and cGMP compliance within the donor center.

Under the Quality Systems Manager, you will review documentation, investigate deviations, release products, and contribute to center training and audits. This role emphasizes training accuracy, documentation integrity, and regulatory adherence.

Qualifications

• Typically requires no previous related experience.
• Developing command of interpersonal communication, organizational and problem-solving skills.
• Ability to understand FDA regulations.
• Strong integrity and commitment to quality and compliance.
• Proficiency with computers.
• Ability to work flexible scheduling to meet business needs.
• Performs basic document review and employee observations.
• 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.

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 related to product quality and/or donor safety.
• Inspects and releases incoming supplies. Investigates and reports supplies have not met quality specifications and requirements prior to use.
• Performs documentation review for unsuitable test results.
• 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.
• 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.
• Assist the Quality Systems Manager to ensure center training programs follow procedural requirements as defined in the donor center SOP and/or training programs 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.
• Summary: 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.

Skills

Interpersonal communication

Organizational skills

Problem-solving

FDA regulations

Quality compliance

Mathematics

Legible handwriting

Computers

SOPs & protocols

cGMP knowledge

Education

High school diploma or GED

Tools

None

Job description

Grifols is seeking a Quality Systems Associate in Inkster, MI, to support quality assurance, training, and cGMP compliance within the donor center.

Under the Quality Systems Manager, you will review documentation, investigate deviations, release products, and contribute to center training and audits. This role emphasizes training accuracy, documentation integrity, and regulatory adherence.