Manufacturing Specialist-35326

ProQuality Network; United States; Hybrid; USD 90,000 - 120,000; Full time

Job summary

ProQuality Network is seeking a Specialist Manufacturing to provide technical expertise in process monitoring, investigations, validation, change control, and continuous improvement within a GMP environment.

You will work cross-functionally with Manufacturing, Quality, Process Development, and Engineering to ensure compliant, reliable manufacturing performance and operational excellence. Strong Spanish/English communication and documentation skills are valued.

Qualifications

• Master’s degree with 2+ years of Manufacturing Operations experience.
• Bachelor’s degree with 4+ years of Manufacturing Operations experience.
• Associate degree with 8+ years of Manufacturing Operations experience.
• High School Diploma/GED with 10+ years of Manufacturing Operations experience.

Responsibilities

• Support manufacturing operations through process monitoring and continuous improvement.
• Author investigations, NCs, CAPAs and root-cause analyses.
• Monitor process performance, identify trends and recommend corrective actions.
• Maintain manufacturing procedures and GDP documentation.
• Assist with process validation activities and protocol development.
• Participate in change control and equipment modification implementations.
• Support New Product Introductions (NPI) and training.
• Contribute to quarterly process monitoring reports and trend analyses.
• Collaborate with cross-functional teams for inspections and audits.
• Participate in special projects and continuous improvement initiatives.

Skills

Manufacturing operations experience

Analytical thinking

Troubleshooting

Technical writing

Communication skills

Independent work

Project management

Collaboration

Education

Master’s degree with 2+ years of Manufacturing Operations experience

Bachelor’s degree with 4+ years of Manufacturing Operations experience

Associate degree with 8+ years of Manufacturing Operations experience

High School Diploma/GED with 10+ years of Manufacturing Operations experience

Tools

TrackWise

Veeva

MES

SmartSheet

Power BI

Spotfire

CDOCS

Copilot

ChatGPT

Job description

The Specialist Manufacturing supports manufacturing operations by providing technical expertise in process monitoring, investigations, process validation, change control, continuous improvement, and quality systems. This role works cross-functionally with Manufacturing, Quality, Process Development, and Engineering teams to ensure compliance, operational excellence, and reliable manufacturing performance within a GMP-regulated environment.

Key Responsibilities

• Support manufacturing operations through process monitoring, troubleshooting, and continuous improvement initiatives.
• Author and support investigations, non-conformances (NCs), CAPAs, and root cause analyses using established methodologies such as Fishbone, 5 Whys, and Kepner-Tregoe.
• Monitor process performance, identify trends, and recommend corrective and preventive actions.
• Support the generation, revision, and maintenance of manufacturing procedures and technical documentation in compliance with Good Documentation Practices (GDP).
• Assist with process validation activities, including protocol development, execution support, data collection, and report generation.
• Participate in change control activities and support implementation of process and equipment modifications.
• Support New Product Introductions (NPI) by assessing documentation, training, materials, and manufacturing requirements.
• Contribute to quarterly process monitoring reports and trend analysis activities.
• Collaborate with cross-functional teams to support regulatory inspections, audits, and compliance initiatives.
• Participate in special projects and continuous improvement initiatives as assigned.

Required Qualifications

• Master’s degree with 2+ years of Manufacturing Operations experience; OR
• Bachelor’s degree with 4+ years of Manufacturing Operations experience; OR
• Associate degree with 8+ years of Manufacturing Operations experience; OR
• High School Diploma/GED with 10+ years of Manufacturing Operations experience.

Preferred Qualifications

• Educational background in Life Sciences, Biology, Chemistry, Engineering, or a related scientific discipline.
• Experience supporting bioprocessing manufacturing operations in a GMP-regulated environment.
• Knowledge of process monitoring, investigations, CAPA management, process validation, and change control systems.
• Familiarity with Lean Manufacturing principles and continuous improvement methodologies.
• Experience with TrackWise, Veeva, MES, SmartSheet, Power BI, Spotfire, CDOCS, Copilot, ChatGPT, and related manufacturing systems.
• Strong technical writing, presentation, and communication skills in both English and Spanish.
• Technical knowledge of bioprocessing unit operations.
• Root Cause Analysis and problem-solving skills.
• Strong analytical and troubleshooting abilities.
• Ability to work independently with minimal supervision.
• Strong organizational and project management skills.
• Excellent interpersonal and collaboration skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Team-oriented mindset with a commitment to quality, compliance, and operational excellence.