On-the-Floor QA Specialist: cGMP & Compliance

Mirus Consulting Group; Juncos (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

mîrus Consulting Group in Humacao, Puerto Rico is seeking a Specialist QA to support cGMP quality operations in a biotechnology manufacturing environment. You will perform on-the-floor QA reviews, document control, and support quality systems while collaborating with cross-functional teams.

The role requires a Bachelor's in Science or Engineering, 4+ years in QA/validation/compliance, and bilingual English/Spanish. Experience with GxP validation, deviations, CAPA, and audits is preferred.

Qualifications

• Bachelor's degree in Science or Engineering.
• 4+ years of QA, manufacturing, validation, or compliance in a regulated setting.
• Strong knowledge of cGMP regulations and Quality Systems.
• Bilingual proficiency in English and Spanish.

Responsibilities

• On-the-floor QA review, approval, and tracking of cGMP processes and records.
• Support internal and external audits and inspections.
• Maintain Quality Management System and document controls.
• Lead or support CAPA, deviations, and change control activities.
• Support New Product Introduction (NPI) initiatives.
• Collaborate cross-functionally with Manufacturing, Validation, QA/QC, and Engineering.

Skills

Quality Assurance

cGMP knowledge

Deviations & CAPA

Cross-functional collaboration

Regulatory liaison

Documentation review

Spanish & English

Validation expertise

Education

Bachelor's degree in Science or Engineering

Tools

SAP

MES

Trackwise

EDMQ

DQMS

EBR

Job description

mîrus Consulting Group in Humacao, Puerto Rico is seeking a Specialist QA to support cGMP quality operations in a biotechnology manufacturing environment. You will perform on-the-floor QA reviews, document control, and support quality systems while collaborating with cross-functional teams.

The role requires a Bachelor's in Science or Engineering, 4+ years in QA/validation/compliance, and bilingual English/Spanish. Experience with GxP validation, deviations, CAPA, and audits is preferred.