Overview
Quality Systems Associate Jobs in San Antonio, Texas, USA at Grifols, S.A
Quality Systems Associate
Summary:
Under the supervision of the Quality Systems Manager, perform quality assurance and training functions to ensure compliance with regulations and protocols.
Primary responsibilities:
Review equipment QC and maintenance records weekly.
Investigate deviations and complaints related to product quality and donor safety.
Inspect and release incoming supplies, ensuring quality standards.
Review documentation for unsuitable test results.
Assist in ensuring compliance with cGMP, SOPs, and regulatory requirements.
Perform product release activities and review related documentation.
Review lookback and waste shipment documentation.
Review donor events and exceptions impacting safety and quality.
Review donor deferral notifications.
Ensure proper handling of plasma processing documentation.
Training responsibilities:
Assist in maintaining training programs and records.
Conduct employee training observations.
Implement training on directives and SOP changes.
Additional duties (as needed):
Review and approve donor reinstatement activities.
Assist with internal audits.
Qualifications:
High school diploma or GED; certifications if applicable.
No previous experience required.
Occupational demands:
Work in a plasma center with exposure to biological fluids, electrical equipment, and extreme cold. Use personal protective equipment. Sit and stand for extended periods, with occasional bending, twisting, and lifting up to 50 lbs. Good hearing and vision are essential. Ability to communicate effectively and work independently.
Note:
This description is not exhaustive; additional duties may be assigned.
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Title: Quality Systems Associate
Company: Grifols, S.A
Location: San Antonio, Texas, USA
Category: Quality Assurance – QA/QC, Healthcare (Data Scientist)