Onsite GMP Manufacturing Specialist – NPI & Process Lead

ProQuality Network; Juncos (PR); Sur place; USD 60 000 - 85 000; Plein temps

Résumé du poste

ProQuality Network is seeking a Specialist Manufacturing to support execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and New Product Introductions (NPI).

With minimal supervision, the Specialist applies process, operational, and scientific expertise, along with basic compliance knowledge and analytical and troubleshooting skills, to support manufacturing operations.

Qualifications

• Requires hands-on experience with manufacturing operations and GMP environments.
• Experience initiating, revising, and approving manufacturing procedures.
• Experience on-the-floor support and analyzing process performance data.
• Familiarity with NPI activities, documentation, materials, and training requirements.
• Experience supporting CAPA, NCRs, and trend evaluations.

Responsabilités

• Initiate, revise, and approve manufacturing procedures reflecting current operations.
• Serve as document owner and maintain accurate process documentation.
• Assess process performance via floor observations and data review.
• Plan and implement improvements for process efficiency and reliability.
• Provide troubleshooting support for manufacturing issues.
• Assist in generating training materials and deliver training when needed.
• Support regulatory inspections and New Product Introductions (NPI) processes.

Connaissances

Bioprocessing

GMP knowledge

Regulatory knowledge

Cross-functional teamwork

Technical writing

Presentation skills

Formation

Doctorate degree

Master's degree + 2 years manufacturing operations experience

Bachelor's degree + 4 years manufacturing operations experience

Associate's degree + 8 years manufacturing operations experience

High school diploma/GED + 10 years manufacturing operations experience

Description du poste

ProQuality Network is seeking a Specialist Manufacturing to support execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and New Product Introductions (NPI).

With minimal supervision, the Specialist applies process, operational, and scientific expertise, along with basic compliance knowledge and analytical and troubleshooting skills, to support manufacturing operations.