Quality Systems Associate - QA & Training in Plasma Center

Grifols; Pueblo (CO); Sur place; USD 27 000 - 36 000; Plein temps

Avantages offerts par ce poste

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Paid Time Off

401(k) Match

Tuition Reimbursement

Résumé du poste

Grifols is seeking a Quality Systems Associate in Pueblo, CO to support quality assurance and training under the Quality Systems Manager. The role focuses on ensuring compliance with cGMP, SOPs, and regulatory requirements and includes reviewing records, investigating deviations, and assisting with product release activities.

You will help maintain training records, observe staff competency, and participate in center audits.

Qualifications

• High school diploma or GED.
• No prior related experience required.
• Knowledge of FDA regulations and cGMP.
• Ability to work in a plasma center environment and handle documentation.

Responsabilités

• Completes weekly review of equipment QC and maintenance records.
• Documents, investigates, and performs root-cause analysis for deviations and customer complaints related to quality and donor safety.
• Inspects and releases incoming supplies; investigates unmet quality specifications.
• Performs documentation review for unsuitable test results.
• Assists with product release activities and regulatory compliance.
• Reviews donor center records and training materials.

Connaissances

Quality assurance

Training

Root-cause analysis

Documentation review

cGMP knowledge

FDA regulations

Donor safety

SOP compliance

Problem solving

Attention to detail

Formation

High school diploma or GED

Description du poste

Grifols is seeking a Quality Systems Associate in Pueblo, CO to support quality assurance and training under the Quality Systems Manager. The role focuses on ensuring compliance with cGMP, SOPs, and regulatory requirements and includes reviewing records, investigating deviations, and assisting with product release activities.

You will help maintain training records, observe staff competency, and participate in center audits.