GMP Manufacturing Specialist - Process & Quality

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 55,000 - 83,000; Full time

Job summary

BioPharma Consulting JAD Group seeks a Specialist Manufacturing to support execution of bioprocessing operations and quality systems in a regulated environment. Under minimal supervision, you will manage non-conformances, process validation, procedure writing, training, and new product introductions while maintaining cGMP compliance.

You will collaborate across functions to drive CAPA, document ownership, and process improvements.

Qualifications

• PhD or MS/BS with manufacturing ops experience preferred.
• Experience with deviations management and CAPA.
• Knowledge of cGMP and regulatory inspections.

Responsibilities

• Initiate and approve manufacturing procedures; own documents.
• Assess process performance and implement improvements.
• Provide troubleshooting and training support.
• Ensure EBR and MBR alignment with processes.
• Lead change controls and CCRB packages.

Skills

Bioprocessing

GMP operations

Regulatory knowledge

Cross-functional teams

Communication

Documentation

Project management

Process monitoring

GDP

Bilingual English/Spanish

Education

PhD

MS + 2 years experience

BS + 4 years experience

AS + 8 years experience

HS/GED + 10 years experience

Tools

Veeva Vault

TrackWise

Smartsheet

CDOCs

Job description

BioPharma Consulting JAD Group seeks a Specialist Manufacturing to support execution of bioprocessing operations and quality systems in a regulated environment. Under minimal supervision, you will manage non-conformances, process validation, procedure writing, training, and new product introductions while maintaining cGMP compliance.

You will collaborate across functions to drive CAPA, document ownership, and process improvements.