Quality Systems Associate

Grifols - Little Rock, AR

Full-time - Entry Level

Little Rock, AR

Chemical Manufacturing

About the position

The Quality Systems Associate at Grifols plays a crucial role in ensuring compliance with internal and external regulations related to quality assurance and training functions. This position supports the Quality Systems Manager in maintaining high standards of product quality and donor safety, contributing to the overall mission of improving healthcare outcomes globally.

Responsibilities

• Completes weekly review of equipment QC and maintenance records.
• Documents, investigates, and performs root-cause analysis for deviations and customer complaints related to product quality and donor safety.
• Inspects and releases incoming supplies, ensuring they meet quality specifications before use.
• Performs documentation review for unsuitable test results.
• Assists the Quality Systems Manager in ensuring compliance with cGMP regulations, SOPs, and regulatory requirements.
• Performs all product release activities and reviews related documentation.
• Conducts training observations to ensure staff competency prior to independent work.
• Creates, maintains, and audits training records to ensure compliance.
• Reviews and approves deferred donor reinstatement activities when required.
• Performs review of monthly trending reports and donor adverse events reports.

Requirements

• High school diploma or GED required.
• Basic understanding of cGMP and quality systems.
• Developing command of interpersonal communication, organizational, and problem-solving skills.
• Ability to understand FDA regulations and follow SOPs and protocols.
• Proficiency with computers and basic document review skills.

Nice-to-haves

• Associate's degree in a relevant field is preferred.
• Certification as a Donor Center Technician is beneficial.

Benefits

• Health insurance coverage.
• 401k retirement savings plan.
• Paid time off and holidays.