Grifols · 13 hours ago
Quality Systems Associate
Florida, United States
Full-time
Onsite
New Grad, Entry Level
0+ years expGrifols is a global healthcare company that has been dedicated to improving health and well-being since 1909. The Quality Systems Associate will support quality assurance and training functions to ensure compliance with regulations and protocols, while also performing product release activities and assisting in training programs.
BiotechnologyHealth CareManufacturing
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. Duties include:
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
Assist the Quality Systems Manager to ensure center training programs follow procedural requirements as defined in the donor center SOP and/or training programs documents. Duties include:
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
On an occasional basis, when the Quality Systems Manager is absent, the Quality Systems Associate may be required to perform the following duties:
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
Qualification
Required
High school diploma or GED
Is certified and maintains certification as a Donor Center Technician
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
Ability to understand and follow SOP's 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
Typically requires no previous related experience
Company
Grifols
Grifols is a global healthcare company.
10001+ employees
H1B Sponsorship
Grifols has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
2022 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.51BKey Investors
Michael J. Fox Foundation
2025-01-14Grant· $21M
2024-06-04Post Ipo Debt· $1.41B
2024-04-23Post Ipo Debt· $1.07B
Leadership Team
Camille Alpi
Chief Human Resources Officer
Víctor Deu
Director of Planning & Control Department
Recent News
2025-12-24
Pharma Letter
2025-11-28
2025-11-19
Company data provided by crunchbase