GMP Manufacturing Quality & Compliance Specialist

Mirus Consulting Group; Juncos (PR); Sur place; USD 70 000 - 100 000; Plein temps

Résumé du poste

mîrus Consulting Group is seeking a Manufacturing Specialist to provide technical leadership and ensure GMP-compliant manufacturing operations. The role supports deviation management, CAPAs, change control activities, risk assessments, and documentation management while driving continuous improvement and operational efficiency.

Responsibilities include leading investigations, editing CDOC, and collaborating with QA, QC, Engineering, Validation, Supply Chain, and Operations to improve

Qualifications

• Doctorate degree in a related field.
• Master’s degree with 3+ years of Manufacturing Operations experience.
• Bachelor’s degree with 5+ years of Manufacturing Operations experience.

Responsabilités

• Support daily manufacturing operations to ensure safe, compliant, and efficient production processes.
• Lead investigations related to deviations, non-conformances, and process excursions.
• Author, review, and manage CAPAs and Change Controls.
• Perform and document risk assessments of manufacturing processes, product quality, and compliance.
• Serve as a CDOC Editor for controlled manufacturing documentation.
• Collaborate with QA, QC, Engineering, Validation, Supply Chain, and Operations.
• Monitor manufacturing metrics and recommend process improvements.
• Ensure activities comply with GMP regulations, site procedures, and regulatory requirements.
• Support audits, inspections, and regulatory commitments as required.
• Participate in continuous improvement initiatives and operational excellence projects.

Formation

Doctorate degree

Master’s degree

Bachelor’s degree

Description du poste

mîrus Consulting Group is seeking a Manufacturing Specialist to provide technical leadership and ensure GMP-compliant manufacturing operations. The role supports deviation management, CAPAs, change control activities, risk assessments, and documentation management while driving continuous improvement and operational efficiency.

Responsibilities include leading investigations, editing CDOC, and collaborating with QA, QC, Engineering, Validation, Supply Chain, and Operations to improve