Quality Systems Associate

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 and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Quality Systems Associate

• Pay scale of $19.38–$26.22/hour, depending on training, education and experience.
• Eligible to participate in up to 5% of the company bonus pool.
• Benefits include medical, PTO, up to 5% 401(k) match, and tuition reimbursement.
• Opportunity for professional growth and career progression.
• Final date to receive applications: 02/23/26 @ 11:59 PM local time.

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.

• Complete weekly review of equipment QC and maintenance records.
• Document, investigate, and perform root‑cause analysis for deviations and customer complaints related to product quality and/or donor safety.
• Inspect and release incoming supplies; investigate and report supplies that have not met quality specifications.
• Perform documentation review for unsuitable test results.
• Assist the Quality Systems Manager to ensure cGMP regulation, SOPs, and regulatory requirements are followed.
• Perform all product release activities.
• Review look‑back information and documentation.
• Review waste shipment documentation.
• Review unexpected plasmapheresis events, including electronic donor chart and related documentation.
• 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.
• Assist with center training programs, create and audit training records, observe employee training, and conduct required training activities.
• When Quality Systems Manager is absent, review and approve deferred donor reinstatement activities and assist with completion of the internal donor center audit.
• Perform review of monthly trending reports and donor adverse events reports.
• Conduct training to address donor center corrective and preventive measures.

Is certified and maintains certification as a Donor Center Technician.

• Strong interpersonal communication, organizational, and problem‑solving skills.
• Understanding of FDA regulations, cGMP, and quality systems.
• Integrity, commitment to quality and compliance.
• Basic knowledge of mathematics and proficient with computers.
• Ability to work flexible scheduling to meet business needs.
• Proficiency in document review and employee observations.
• Good organizational skills and attention to detail.
• Ability to perform primary responsibilities of the Quality Associate role in a proficient manner.
• Proficient written and verbal communication; legible handwriting.

High school diploma or GED required. Obtain state licensures or certifications if applicable.

Typically requires no previous related experience.

• Work performed in a plasma center; exposure to biological fluids and potential infectious organisms.
• Exposure to electrical office and laboratory equipment; exposure to extreme cold below 32 °F while reviewing plasma freezers.
• Use of personal protective equipment (protective eyewear, garments, gloves, cold gear).
• Mostly sitting for 4–6 hours per day and standing for 2–4 hours per day; occasional bending, twisting, and light lifting up to 50 lbs.
• Requires hand and foot coordination, precise movements, and adequate vision and hearing.
• Works independently with minimal guidance.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, sex, gender identity, sexual orientation, religious practices, national origin, pregnancy, childbirth, or related medical conditions, status as a protected veteran or spouse/family member of a protected veteran, or disability. We will consider all qualified applicants in a manner consistent with applicable laws.

NORTH AMERICA: USA: CO-Pueblo: USNC
0701 – Pueblo CO-Moore Ave-TPR

Third Party Agency and Recruiter Notice:
Agencies presenting candidates to Grifols must have an active, non‑expired Grifols Agency Master Services Agreement. All resumes must be sent to a Grifols Recruiter under these terms; otherwise the candidate is considered a Grifols candidate.

Learn more about Grifols:

Req

Type:
Regular Full‑Time

Job Category: MANUFACTURING