Microbiology Method Transfer & Validation Lead

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

Job summary

QRC Group, LLC is seeking a Test Methods Transfer & Validation Specialist – Microbiology to plan, execute, and document method transfers, validations, and verifications across internal and external labs. You will lead cross-functional teams, develop protocols, analyze data for method robustness, and ensure compliance with GMP, GLP, FDA and ISO standards.

This role requires 5+ years in a regulated pharma/biotech setting and bilingual Spanish/English.

Qualifications

• Minimum of 5 years in a regulated industry (pharmaceutical, biotechnology, or medical device) within a Microbiology, Quality Control, or Analytical Development laboratory.
• Hands-on experience conducting microbiological method transfers, validations, and verifications.
• Strong knowledge of cGMP, FDA, USP, EP and other applicable regulatory and compendial requirements.

Responsibilities

• Lead and support test method transfer projects between laboratories, manufacturing sites, or functional areas.
• Develop and execute validation protocols, transfer plans, and supporting technical documentation.
• Perform method validation, verification, and transfer studies in accordance with internal procedures and regulatory requirements.
• Analyze and interpret data to assess method accuracy, precision, repeatability, reproducibility, and robustness.
• Investigate out-of-specification (OOS) results, deviations, nonconformances, and method-related issues.
• Prepare technical reports, summaries, and presentations to communicate study outcomes and recommendations.
• Collaborate with Quality, Engineering, Manufacturing, Research & Development, Regulatory Affairs, and Laboratory Operations teams.
• Ensure compliance with GMP, GLP, ISO standards, FDA regulations, and company quality system requirements.
• Support internal and external audits by providing documentation and technical expertise.
• Identify opportunities for process improvements and implement best practices related to method transfer and validation activities.

Skills

Bilingual in Spanish and English

Microbiology knowledge

Education

Bachelor’s or Master’s degree in Microbiology, Biology

Job description

QRC Group, LLC is seeking a Test Methods Transfer & Validation Specialist – Microbiology to plan, execute, and document method transfers, validations, and verifications across internal and external labs. You will lead cross-functional teams, develop protocols, analyze data for method robustness, and ensure compliance with GMP, GLP, FDA and ISO standards.

This role requires 5+ years in a regulated pharma/biotech setting and bilingual Spanish/English.