GMP Manufacturing & Quality Systems Specialist

ProQuality Network; United States; Hybrid; USD 85,000 - 120,000; Full time

Job summary

ProQuality Network seeks a Manufacturing Specialist to support regulated GMP operations in a hybrid environment. The role emphasizes technical writing, deviation investigations, and collaboration across Manufacturing, Quality, and Engineering teams.

Ideal candidates bring bioprocess manufacturing experience, strong process validation knowledge, and proficiency in data analysis and documentation to ensure cGMP compliance and continuous improvement in a pharmaceutical setting.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• Experience in GMP/biopharma manufacturing environments.
• Strong analytical and writing skills; cross-functional collaboration.

Responsibilities

• Support GMP manufacturing and quality operations in regulated environments.
• Own and manage change controls and investigations (RCA, CAPA).
• Assist with process validation, monitoring, and documentation.
• Prepare technical protocols and support NPI activities.

Skills

Bioprocessing operations

Root Cause Analysis

CAPA implementation

Process validation

Statistical analysis

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Master's degree in related field

Tools

TrackWise

Spotfire

CDOCS

Process Monitoring Platforms

Job description

ProQuality Network seeks a Manufacturing Specialist to support regulated GMP operations in a hybrid environment. The role emphasizes technical writing, deviation investigations, and collaboration across Manufacturing, Quality, and Engineering teams.

Ideal candidates bring bioprocess manufacturing experience, strong process validation knowledge, and proficiency in data analysis and documentation to ensure cGMP compliance and continuous improvement in a pharmaceutical setting.