Microbiology Method Transfer & Validation Lead

QRC Group; Aibonito (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

QRC Group seeks a Test Methods Transfer & Validation Specialist - Microbiology in Aibonito, Puerto Rico. The role focuses on planning, executing, and documenting microbiological method transfers, validations, and verifications to ensure robustness and compliance.

You will collaborate with Quality, Regulatory Affairs, Manufacturing, and R&D to drive continuous improvement and adhere to cGMP, FDA, and ISO standards across internal and external laboratories.

Qualifications

• Bachelor's or master's in Microbiology or Biology.
• 5+ years in a regulated pharmaceutical/biotech lab.
• Hands-on microbiology method transfers and validations.
• Knowledge of cGMP, FDA, USP, EP, ISO requirements.

Responsibilities

• Lead microbiological method transfers between labs.
• Develop and execute validation protocols and transfer plans.
• Perform method validation, verification, and transfer studies.
• Analyze data for accuracy, precision, robustness.
• Investigate OOS, deviations, and nonconformances.
• Prepare technical reports and communicate study outcomes.
• Collaborate with Quality, Regulatory, Manufacturing, R&D, Lab Operations.
• Support audits with documentation and expertise.
• Identify opportunities for process improvements.

Skills

Microbiology

cGMP

FDA regulations

USP/EP/ISO

Method validation

Method transfer

Quality control

Analytical development

Documentation

Regulatory compliance

Spanish-English

Education

Bachelor's or Master's in Microbiology/ Biology

Job description

QRC Group seeks a Test Methods Transfer & Validation Specialist - Microbiology in Aibonito, Puerto Rico. The role focuses on planning, executing, and documenting microbiological method transfers, validations, and verifications to ensure robustness and compliance.

You will collaborate with Quality, Regulatory Affairs, Manufacturing, and R&D to drive continuous improvement and adhere to cGMP, FDA, and ISO standards across internal and external laboratories.