Senior QA Specialist - Clinical & Manufacturing Quality

Grifols; San Marcos (TX); Sur place; USD 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Health insurance

401(k) plan with company match

Paid vacation

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Complaint handling

Regulatory awareness

Documentation & data analysis

Training & mentoring

Project coordination

Independent work

Formation

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

Outils

Microsoft Word

Excel

PowerPoint

Description du poste

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.