QA Manager – Pharma Facilities & Compliance

QuVa - Advancing Healthcare Possibilities; Bloomsbury (NJ); Presencial; USD 114.000 - 156.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health and dental insurance

401k retirement program with company 

Paid time off: 22 days + 8 holidays

Career advancement opportunities

Descripción de la vacante

Quva is seeking a Manager, Quality Assurance – Facilities Maintenance at its Bloomsbury, NJ site to oversee QA activities for facility maintenance and engineering projects. You will ensure documentation, compliance with FDA/cGMP standards, and lead investigations into deviations and equipment issues.

You will manage QA staff, review work orders, and implement CAPAs while maintaining calibration and testing records.

Formación

• Bachelor’s Degree in Life Science or another related field.
• 3+ years’ supervisory or management experience.
• 5+ years’ experience in Quality Assurance / cGMP / FDA regulated industry.
• Understanding of Good Documentation Practices.
• Experience with Maintenance Safety practices and protocols.
• Knowledge of ISO 5/7 cleanroom gowning.

Responsabilidades

• Manages Quality Assurance – Facility / Maintenance staff
• Reviews, approves and ensures completion of all facility related work orders for the manufacturing site
• Ensures compliance with clean room standards during all facility related projects
• Oversees investigations and documenting deviations or equipment malfunctions
• Develops corrective and preventive actions (CAPA)
• Monitors environmental monitoring data to ensure ongoing compliance
• Maintains QA records for facilities/maintenance and testing equipment
• Assists in developing QA policies and procedures
• Communicates discrepancies to appropriate departments
• Enforces personnel policies and procedures

Conocimientos

Leadership

Quality Assurance

Regulatory compliance

Technical writing

Communication

Educación

Bachelor's Degree in Life Science

Descripción del empleo

Quva is seeking a Manager, Quality Assurance – Facilities Maintenance at its Bloomsbury, NJ site to oversee QA activities for facility maintenance and engineering projects. You will ensure documentation, compliance with FDA/cGMP standards, and lead investigations into deviations and equipment issues.

You will manage QA staff, review work orders, and implement CAPAs while maintaining calibration and testing records.