Quality Systems Associate: Training & Compliance

Grifols, S.A; Savannah (GA); Vor Ort; USD 52.000 - 75.000; Vollzeit

Zusammenfassung

Grifols, S.A. is seeking a Quality Systems Associate to support QA and training functions within a donor center. You will ensure compliance with internal procedures, review records, and participate in product release activities.

Under supervision, you will conduct training, maintain training documentation, and assist with center audits, while supporting regulatory requirements and cGMP practices.

Qualifikationen

• Developing command of interpersonal communication, organizational and problem-solving skills.
• Ability to understand FDA regulations.
• Strong integrity and commitment to quality and compliance.

Aufgaben

• 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.
• Assist 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.

Kenntnisse

Interpersonal skills

Organizational skills

Problem-solving

FDA regulations

Attention to detail

Quality mindset

Ausbildung

High school diploma or GED

State licensures/certifications

Tools

Computers

Jobbeschreibung

Grifols, S.A. is seeking a Quality Systems Associate to support QA and training functions within a donor center. You will ensure compliance with internal procedures, review records, and participate in product release activities.

Under supervision, you will conduct training, maintain training documentation, and assist with center audits, while supporting regulatory requirements and cGMP practices.