Quality Systems Specialist - Donor Center

Grifols, S.A; Town of Florida (NY); On-site; USD 60,000 - 85,000; Full time

Job summary

Grifols, S.A. is seeking a Quality Systems Associate to support the Quality Systems Manager with quality assurance and training to ensure compliance with internal and external regulations.

You will review documentation, perform QA activities, ensure cGMP compliance, and assist with center training programs. This role operates in a plasma center environment and requires attention to detail and strong problem-solving skills.

Qualifications

• High school diploma or GED required; state licensures may apply.
• Ability to understand FDA regulations and regulatory requirements.
• Strong attention to detail and ability to work independently.

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.
• Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed.
• 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.
• 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 of deferred donor reinstatement activities.
• 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.

Skills

Interpersonal communication

Organizational skills

Problem-solving

FDA regulations understanding

Quality and compliance

Mathematics

Legible handwriting

Computer proficiency

Flexibility in scheduling

Documentation review

Education

High school diploma or GED

Job description

Grifols, S.A. is seeking a Quality Systems Associate to support the Quality Systems Manager with quality assurance and training to ensure compliance with internal and external regulations.

You will review documentation, perform QA activities, ensure cGMP compliance, and assist with center training programs. This role operates in a plasma center environment and requires attention to detail and strong problem-solving skills.