QA Facilities Maintenance Manager (GMP/Cleanroom)

QuVa Pharma; Bloomsbury (NJ); Vor Ort; USD 114.000 - 156.000; Vollzeit

Benefits dieser Stelle

Health, dental & vision benefits

401k with company match

22 paid days off + 8 holidays

Career advancement opportunities

Zusammenfassung

Quva Pharma in New Jersey seeks a Manager of Quality Assurance - Facilities Maintenance to lead QA facility programs and oversee maintenance projects at our manufacturing site. The role emphasizes compliance, precision, and strong documentation practices to ensure safety, efficacy and quality in pharmaceutical operations.

You will guide a technical team, ensure cleanroom and regulatory standards, review investigations, and drive CAPAs while maintaining QA records and coordinating with

Qualifikationen

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

Aufgaben

• Lead QA Facility/Maintenance staff and oversee site work orders.
• Ensure cleanroom compliance during projects.
• Oversee investigations of deviations and equipment malfunctions.
• Develop and implement corrective and preventive actions.
• Monitor environmental monitoring data for facilities/maintenance.
• Maintain FDA 503B and cGMP compliance records.
• Maintain testing equipment records, calibration and certification.
• Contribute to QA policies for facility/maintenance.
• Communicate discrepancies to relevant departments.
• Enforce applicable personnel policies.

Kenntnisse

Supervision

QA

cGMP

FDA regs

Documentation

Cleanroom ISO7

Ausbildung

Bachelor's in Life Science

Jobbeschreibung

Quva Pharma in New Jersey seeks a Manager of Quality Assurance - Facilities Maintenance to lead QA facility programs and oversee maintenance projects at our manufacturing site. The role emphasizes compliance, precision, and strong documentation practices to ensure safety, efficacy and quality in pharmaceutical operations.

You will guide a technical team, ensure cleanroom and regulatory standards, review investigations, and drive CAPAs while maintaining QA records and coordinating with