Senior QA Specialist - Clinical & Manufacturing Quality

Grifols; San Marcos (TX); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

401(k) plan with company match

Paid vacation

Job summary

Grifols is seeking a QA Sr. Specialist to provide essential oversight of clinical and manufacturing testing, handle complaints, and lead quality improvement initiatives. You will interface with auditors and internal departments to ensure compliance with FDA, ISO, and CFR requirements.

The role requires strong knowledge of QMS and experience in coordinating cross-functional teams, SOP updates, and CAPA projects within a regulatory framework.

Qualifications

• BA/BS in biology, chemistry, biochemistry or related field.
• Quality certifications such as MT, MLS, CLS or ASQ or equivalent are a plus.
• 5–8 years quality experience in complaint handling and investigation or a Master’s with 3–6 years.
• Knowledge of CAP, CLIA, CFR, FDA, ISO, MDR requirements.

Responsibilities

• Independently handles complaints and investigations, assigns actions.
• Review/update/create SOPs to standardize processes.
• Lead cross-functional teams for product quality improvements.
• Plan and conduct internal audits per FDA, ISO, MDR.
• Coordinate with regulators and auditors; ensure timely follow-up actions.

Skills

Complaint handling

Regulatory awareness

Documentation & data analysis

Training & mentoring

Project coordination

Independent work

Education

BA/BS in biology, chemistry, biochemistry or related field

Tools

Microsoft Word

Excel

PowerPoint

Job description

Grifols is seeking a QA Sr. Specialist to provide essential oversight of clinical and manufacturing testing, handle complaints, and lead quality improvement initiatives. You will interface with auditors and internal departments to ensure compliance with FDA, ISO, and CFR requirements.

The role requires strong knowledge of QMS and experience in coordinating cross-functional teams, SOP updates, and CAPA projects within a regulatory framework.