Quality Systems Specialist — GMP & Training

Grifols; Los Angeles (CA); On-site; USD 33,062 - 45,460; Full time

Benefits offered by this job

Medical, Dental, Vision insurance

401(k) match

Tuition reimbursement

Paid time off

Job summary

Grifols in Van Nuys, CA is seeking a Quality Systems Associate to perform quality assurance and training functions ensuring regulatory and protocol compliance under the supervision of the Quality Systems Manager.

Responsibilities include reviewing equipment QC, investigating deviations, inspecting supplies, and maintaining training records while upholding cGMP standards and company policies across the donor center operations.

Qualifications

• High school diploma or GED.
• State licensures or certifications may apply.
• Typically no previous related experience required.

Responsibilities

• Complete weekly review of equipment QC and maintenance records.
• Document, investigate, and perform root‑cause analysis for deviations and customer complaints, specifically related to product quality and/or donor safety.
• Inspect and release incoming supplies; investigate and report supplies that have not met quality specifications and requirements prior to use.
• Perform documentation review for unsuitable test results.
• Assist the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed.
• Perform all product release activities.
• Review lookback information and documentation.
• Review waste shipment documentation.
• Review unexpected plasmapheresis events including electronic donor chart and related documentation of exceptions during the donation process.
• Review electronic donor chart exceptions impacting donor eligibility/safety and/or product quality.
• Review donor deferral notifications from competitor centers.
• Review plasma processing documentation to ensure proper freezing, storage and handling of product.

Skills

Interpersonal communication

FDA regulations

Quality assurance

Attention to detail

Legible handwriting

Computer proficiency

SOP adherence

Document review

Organizational skills

Problem solving

Education

High school diploma or GED

Job description

Grifols in Van Nuys, CA is seeking a Quality Systems Associate to perform quality assurance and training functions ensuring regulatory and protocol compliance under the supervision of the Quality Systems Manager.

Responsibilities include reviewing equipment QC, investigating deviations, inspecting supplies, and maintaining training records while upholding cGMP standards and company policies across the donor center operations.