Overview
Quality Systems Associate Jobs in Stamford, Connecticut, USA at Grifols, S.A
Quality Systems Associate Stamford, Connecticut
Apply Now
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine, developing, producing, and marketing innovative medicines, solutions, and services in more than 110 countries and regions.
Quality Systems Associate
Summary
Under the supervision of the Quality Systems Manager, perform quality assurance and training functions to ensure compliance with internal and external regulations and protocols.
Primary Responsibilities
Complete weekly reviews of equipment QC and maintenance records.
Document, investigate, and perform root-cause analysis for deviations and customer complaints related to product quality and donor safety.
Inspect and release incoming supplies, investigating and reporting any that do not meet quality specifications.
Review documentation for unsuitable test results.
Assist the Quality Systems Manager to ensure compliance with cGMP regulations, SOPs, and regulatory requirements, including:
Perform all product release activities.
Review lookback information and documentation.
Review waste shipment documentation.
Review unexpected plasmapheresis events and related documentation.
Review electronic donor chart exceptions affecting donor eligibility, safety, or product quality.
Review donor deferral notifications from other centers.
Review plasma processing documentation for proper handling and storage.
Training Responsibilities
Assist in ensuring center training programs follow SOPs and training documents.
Duties include:
Create, maintain, and audit training records.
Perform employee training observations to ensure competency.
Conduct training on SOPs, directives, and training program updates.
When the Manager is absent, the Associate may:
Review and approve deferred donor reinstatement activities.
Assist with internal audits.
Additional Responsibilities
Maintain certification as a Donor Center Technician.
Knowledge, Skills, and Abilities
Develop interpersonal, organizational, and problem-solving skills.
Understand FDA regulations and cGMP principles.
Strong integrity, attention to detail, and proficiency with computers.
Ability to work flexible hours and perform documentation reviews.
Education
High school diploma or GED; certifications as applicable.
Experience
No prior experience required.
Occupational Demands
Work involves exposure to biological fluids, electrical equipment, extreme cold, and requires PPE.
Mostly sitting, with some standing, bending, and lifting up to 50 lbs.
Good hearing, vision, and communication skills are essential.
#Biomatusa
Third-party agency and recruiter notice:
Agencies must have an active Master Services Agreement with Grifols and be engaged for specific roles.
Equal Opportunity Employment:
Grifols provides equal employment opportunities regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or other protected characteristics.
Learn more about Grifols at
#J-18808-Ljbffr
Title: Quality Systems Associate
Company: Grifols, S.A
Location: Stamford, Connecticut, USA
Category: Healthcare (Data Scientist), Quality Assurance – QA/QC
