Remote GMP Manufacturing Specialist

ProQuality Network; United States; Hybrid; USD 65.000 - 95.000; Teilzeit

Benefits dieser Stelle

Remote work option

6-month contract

Zusammenfassung

ProQuality Network seeks a Manufacturing Specialist in a regulated environment on a contract basis. The role supports manufacturing and quality systems, including non-conformance management, process validation, and new product introductions.

The candidate applies scientific and compliance expertise with minimal supervision, potentially serving as a process owner for select systems. The position emphasizes strong documentation, data analysis, and cross-functional collaboration, with

Qualifikationen

• Educational background in Science or Industrial Engineering preferred.
• Experience in manufacturing, process development, or quality assurance within biotech or pharmaceutical industry.
• Experience in compliance, problem-solving, project management and quality systems.

Aufgaben

• Initiate, revise, and approve manufacturing procedures; ensure alignment with current operations.
• Serve as document owner for assigned procedures.
• Assess process performance through floor observations and data review.
• Identify, plan, and implement process improvement initiatives.
• Provide technical troubleshooting support.
• Assist in the development of training materials and delivery of technical training.
• Support establishment of process monitoring parameters and control limits.
• Collect and analyze process monitoring data.
• Support deviation assessments and timely completion of quarterly process monitoring reports.
• Ensure timely triage of non-conformances and author investigation reports.
• Manage NC/CAPA closure within timelines and monitor incident data.
• Assist in development of process validation protocols and reports.
• Support regulatory inspections and NPI activities; assess documentation, materials, training, and equipment requirements.

Kenntnisse

Quality management

Cross-functional teams

English communication

Data analysis

Microsoft Office

TrackWise/Veeva

SAP ERP

Process validation

Non-conformance management

CAPA management

Documentation writing

Ausbildung

Master’s degree in Science or related

Bachelor’s degree in Science/Engineering

Associate degree in related field

High School Diploma/GED

Tools

SAP

TrackWise

Veeva Systems

Jobbeschreibung

ProQuality Network seeks a Manufacturing Specialist in a regulated environment on a contract basis. The role supports manufacturing and quality systems, including non-conformance management, process validation, and new product introductions.

The candidate applies scientific and compliance expertise with minimal supervision, potentially serving as a process owner for select systems. The position emphasizes strong documentation, data analysis, and cross-functional collaboration, with