Senior Microbiologist - Quality & Risk Specialist (Hybrid)

REQ Solutions Pvt Ltd; Saint Paul (MN); Hybride; USD 110 000 - 150 000; Plein temps

Résumé du poste

REQ Solutions Pvt Ltd in Minnesota seeks an experienced Sr. Microbiologist to provide technical support for contract manufactured devices, risk assessments, and quality system activities across the organization.

The role demands collaboration with cross-functional teams to ensure product quality, regulatory compliance, and patient safety. You will author MBERs, evaluate microbiological impact of changes, and mentor junior staff.

Qualifications

• Bachelor's degree in Microbiology or related field.
• Minimum 5 years in microbiology, quality, manufacturing, or related regulated function.
• Strong technical writing and documentation skills.
• Ability to manage multiple projects and priorities.

Responsabilités

• Provide technical support for contract manufactured devices and external manufacturing partners.
• Perform microbiological risk assessments for products, materials, processes, facilities, and supplier changes.
• Author and review Microbiology Evaluation Reports (MBERs) and supporting docs.
• Support investigations, CAPAs, nonconformances, and regulatory readiness activities.
• Communicate microbiological risks and recommendations to stakeholders across regions.

Connaissances

Technical writing

Risk assessment

Cross-functional collaboration

Stakeholder management

Regulatory knowledge

Formation

Bachelor's degree in Microbiology

Description du poste

REQ Solutions Pvt Ltd in Minnesota seeks an experienced Sr. Microbiologist to provide technical support for contract manufactured devices, risk assessments, and quality system activities across the organization.

The role demands collaboration with cross-functional teams to ensure product quality, regulatory compliance, and patient safety. You will author MBERs, evaluate microbiological impact of changes, and mentor junior staff.