Deviation & QC Investigations Specialist – Pharma

Mirus Consulting Group; Juncos (PR); Presencial; USD 85.000 - 110.000; Jornada completa

Descripción de la vacante

mîrus Consulting Group in Humacao, Puerto Rico, specializes in QC and IT validation for pharmaceutical clients. The Specialist Quality Control role focuses on deviation management, lab investigations, and maintaining regulatory compliance within a cGMP environment.

You will collaborate with cross-functional teams to resolve quality events, support CAPA and Change Controls, and apply microbiology and analytical testing expertise to drive continuous improvement across the site.

Formación

• Doctorate or Master’s degree with 2+ years of related experience OR Bachelor’s degree with 4+ years of related experience.

Responsabilidades

• Lead and manage Quality Control deviations.
• Represent QC deviation processes and ensure timely closure and compliance with site procedures.
• Evaluate issues related to Microbiology testing, HPLC analyses, and analytical methods.
• Review laboratory data and analytical results to identify trends and opportunities for improvement.
• Collaborate with QA, Manufacturing, Validation and other teams to resolve quality events and implement corrective actions.
• Support Change Controls, Risk Assessments, and CAPA activities in QC operations.
• Ensure compliance with cGMP, data integrity, site procedures, and global quality standards.
• Support internal audits, regulatory inspections, and responses to quality-related observations.
• Provide technical guidance regarding microbiological and analytical testing investigations.

Conocimientos

Quality Control Deviations

Microbiology

HPLC troubleshooting

Analytical methods

OOS/OOT

CAPA

Change Control

Risk Assessment

Root Cause Analysis

Technical Writing

Educación

Doctorate degree

Master’s degree

Bachelor’s degree

Descripción del empleo

mîrus Consulting Group in Humacao, Puerto Rico, specializes in QC and IT validation for pharmaceutical clients. The Specialist Quality Control role focuses on deviation management, lab investigations, and maintaining regulatory compliance within a cGMP environment.

You will collaborate with cross-functional teams to resolve quality events, support CAPA and Change Controls, and apply microbiology and analytical testing expertise to drive continuous improvement across the site.