Quality Systems & Compliance Specialist

Grifols; Florida; On-site; USD 48,000 - 68,000; Full time

Job summary

Grifols is seeking a Quality Systems Associate in Hollywood, FL to support quality assurance and training functions, ensuring compliance with cGMP and regulatory requirements. You will review equipment QC, investigate deviations, and assist in product release and donor safety processes.

Under supervision, you will maintain training records, conduct observations, and participate in center audits and SOP updates, with a focus on accuracy, documentation integrity, and continuous improvement in

Qualifications

• High school diploma or GED required; certifications optional.
• Experience not required; on-the-job training provided.

Responsibilities

• Completes weekly review of equipment QC and maintenance records.
• Investigates deviations and customer complaints, focusing on product quality and donor safety.
• Inspects and releases incoming supplies.
• Investigates and reports supplies not meeting quality specifications 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 during donation.
• Reviews donor deferral notifications from competitor centers.
• Reviews plasma processing documentation to ensure 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.
• Is certified and maintains certification as a Donor Center Technician.

Skills

FDA regulations

Quality systems

Documentation review

Problem solving

Education

High school diploma or GED

State licensures or certifications (if applicable)

Job description

Grifols is seeking a Quality Systems Associate in Hollywood, FL to support quality assurance and training functions, ensuring compliance with cGMP and regulatory requirements. You will review equipment QC, investigate deviations, and assist in product release and donor safety processes.

Under supervision, you will maintain training records, conduct observations, and participate in center audits and SOP updates, with a focus on accuracy, documentation integrity, and continuous improvement in