Quality Systems Associate — QA, Training & Compliance

Grifols; Worcester (MA); On-site; USD 31,000 - 42,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life insurance

PTO

Paid holidays

401(K) match

Tuition reimbursement

Job summary

Grifols is seeking a Quality Systems Associate to support QA and training functions at its Worcester, MA center. The role ensures regulatory compliance and proper documentation throughout product release and donor safety processes.

Under the Quality Systems Manager, you will review records, investigate deviations, and assist with procedures to maintain cGMP compliance, training programs, and ongoing audits. This is a critical role in maintaining product quality and donor safety.

Qualifications

• High school diploma or GED required; state licensures or certifications if applicable.
• Typically requires no previous related experience.
• Strong understanding of FDA regulations and cGMP concepts; able to follow SOPs and procedures.
• Excellent written and verbal communication; meticulous documentation and record-keeping.

Responsibilities

• Review equipment QC and maintenance records weekly.
• Investigate deviations and customer complaints related to product quality or donor safety.
• Inspect incoming supplies and report non-conforming items.
• Perform documentation review for test results and release activities.
• Assist with training programs and ensure SOP adherence.
• Support the Quality Systems Manager with audits and record maintenance.
• Review donor center documentation and events impacting donor eligibility or safety.

Skills

Interpersonal communication

Organizational skills

Problem solving

FDA regulations knowledge

Attention to detail

Proficiency with computers

Scheduling flexibility

Education

High school diploma or GED

Job description

Grifols is seeking a Quality Systems Associate to support QA and training functions at its Worcester, MA center. The role ensures regulatory compliance and proper documentation throughout product release and donor safety processes.

Under the Quality Systems Manager, you will review records, investigate deviations, and assist with procedures to maintain cGMP compliance, training programs, and ongoing audits. This is a critical role in maintaining product quality and donor safety.