Remote Product Quality Complaints Specialist

Sumitomo Pharma; Salem (OR); Remote; USD 112.000 - 140.000; Vollzeit

Zusammenfassung

Sumitomo Pharma America is seeking a Senior PV Quality Assurance professional to oversee intake, investigations and closure of product complaints across commercial and clinical products. You will collaborate with Pharmacovigilance, Manufacturing, and QA to ensure patient safety and regulatory compliance.

The role requires a Bachelor's degree and at least 4 years in biotech/pharma with strong cGMP knowledge and experience in complaint processes, eQMS and regulatory guidance.

Qualifikationen

• Bachelor’s degree in a related field.
• 4+ years experience in biotech/pharma.
• 3+ years product complaints experience.
• Working knowledge of cGMP requirements.
• Experience with eQMS and complaint databases.

Aufgaben

• Manage intake, assessment, documentation, investigation and closure of product complaints per regulations.
• Receive, evaluate and process product complaints and forward adverse event reports as needed.
• Coordinate investigations with internal/external stakeholders for required information.
• Ensure complaint records are complete, accurate and inspection-ready.
• Maintain compliance with cGMP and quality procedures.
• Review and approve records, communications and closure documentation.

Kenntnisse

FDA/GMP knowledge

Investigation skills

eQMS familiarity

Regulatory compliance

Documentation quality

Communication skills

Multitasking

Ausbildung

Bachelor’s degree in related field

Jobbeschreibung

Sumitomo Pharma America is seeking a Senior PV Quality Assurance professional to oversee intake, investigations and closure of product complaints across commercial and clinical products. You will collaborate with Pharmacovigilance, Manufacturing, and QA to ensure patient safety and regulatory compliance.

The role requires a Bachelor's degree and at least 4 years in biotech/pharma with strong cGMP knowledge and experience in complaint processes, eQMS and regulatory guidance.