Quality Systems & Training Associate (Donor Center)

Grifols; Statesboro (GA); On-site; USD 55,000 - 70,000; Full time

Job summary

Grifols is seeking a Quality Systems Associate to support QA and training functions, ensuring compliance with cGMP and internal SOPs within a plasma center environment. You will review and document QC records, investigate deviations, and assist in product release activities, maintaining donor safety and product quality.

The role involves conducting training, maintaining records, and participating in center audits.

Qualifications

• 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.
• Performs basic document review and employee observations.
• Communicates openly with the CQM on issues noted during reviews.
• Ability to understand and follow SOPs and protocols.
• Ability to perform primary responsibilities of the Quality Associate role in a proficient manner.
• Has a basic understanding of cGMP and quality systems.
• Is able to spend hours sitting and reviewing documentation for accuracy.
• Demonstrates good organizational skills and attention to detail.

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.

Skills

Interpersonal communication

Organizational skills

Problem solving

Attention to detail

Documentation review

Education

High school diploma or GED

Job description

Grifols is seeking a Quality Systems Associate to support QA and training functions, ensuring compliance with cGMP and internal SOPs within a plasma center environment. You will review and document QC records, investigate deviations, and assist in product release activities, maintaining donor safety and product quality.

The role involves conducting training, maintaining records, and participating in center audits.