Microbiology Method Transfer & Validation Lead

QRC; Aibonito (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

QRC Group, LLC is seeking a Test Methods Transfer & Validation Specialist – Microbiology to plan, execute, and document microbiological method transfers, validations, and verification studies in compliance with regulatory requirements. The role ensures robustness, reproducibility, and fit-for-purpose use across internal and external laboratories.

The ideal candidate has a microbiology background, 5+ years in regulated environments, and experience with protocol development and technical

Qualifications

• Bachelor’s or Master’s degree in Microbiology, Biology.
• Minimum of five (5) years of experience 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.
• Experience in method validation, method transfer, analytical testing, quality control, or laboratory operations within the pharmaceutical, biotechnology, medical device, or related regulated industries.
• Experience working in FDA, GMP, GLP, ISO, or other regulated environments.
• Familiarity with protocol development, technical documentation, deviation management, and change control processes.
• Bilingual in Spanish and English (written and spoken).

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

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 microbiological method transfers, validations, and verification studies in compliance with regulatory requirements. The role ensures robustness, reproducibility, and fit-for-purpose use across internal and external laboratories.

The ideal candidate has a microbiology background, 5+ years in regulated environments, and experience with protocol development and technical