Quality Systems & Training Specialist – Plasma Center

Grifols Shared Services North America, Inc; Beaumont (TX); On-site; USD 48,000 - 62,000; Full time

Job summary

Grifols Shared Services North America, Inc. in Beaumont, TX, seeks a Quality Systems Associate to support quality assurance, training, and cGMP compliance at the donor center. You will review deviations, ensure SOP adherence, and assist with center training records and audits.

Responsibilities include documenting investigations, performing product release activities, and supporting root-cause analysis for donor safety and product quality. A high school diploma or GED is required.

Qualifications

• Quality systems understanding and adherence to cGMP.
• Experience reviewing documentation and deviations.
• Ability to perform staff training observations.

Responsibilities

• Completes weekly review of equipment QC and maintenance records.
• Documents, investigates, and performs root-cause analysis for deviations and customer complaints.
• 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.
• 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.

Skills

Quality Systems

cGMP knowledge

Documentation review

Training

Problem solving

Education

High school diploma or GED

Job description

Grifols Shared Services North America, Inc. in Beaumont, TX, seeks a Quality Systems Associate to support quality assurance, training, and cGMP compliance at the donor center. You will review deviations, ensure SOP adherence, and assist with center training records and audits.

Responsibilities include documenting investigations, performing product release activities, and supporting root-cause analysis for donor safety and product quality. A high school diploma or GED is required.