Methods Transfer & Validation Specialist

QRC Group, LLC • Añasco, PR

7d

About The Position

The Methods Transfer & Validation Specialist is responsible for planning, executing, and documenting analytical method transfers, validations, verifications, and method improvement initiatives in compliance with regulatory requirements. This role ensures analytical methods are robust, reproducible, and suitable for their intended use across internal and external laboratories. The specialist collaborates closely with Quality Control, R&D, Manufacturing, and third‑party testing laboratories to support product lifecycle and regulatory submissions.

Requirements

• Bachelor’s or Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline.
• Five years of experience in a regulated industry (pharmaceutical, biotech, or medical devices) in analytical development or quality control laboratory.
• Experience conducting method transfers and validations required.
• Technical writing and documentation ability.
• Bilingual (Spanish/English)(Write/Speak)

Responsibilities

• Coordinate and execute analytical method transfer activities between sending and receiving laboratories.
• Prepare method transfer protocols and reports in accordance with internal SOPs and regulatory expectations.
• Provide technical training and support during method transfer execution.
• Investigate and troubleshoot discrepancies during or after method transfer.
• Develop method validation strategies aligned with ICH, FDA, EMA, USP, and other relevant regulatory guidelines.
• Draft and review validation protocols, including risk assessments and acceptance criteria.
• Perform statistical data analysis and ensure methods meet parameters such as accuracy, precision, specificity, linearity, robustness, and detection limits.
• Prepare method validation reports and ensure completeness and traceability of documentation.
• Serve as a subject matter expert (SME) for analytical methodologies.
• Provide analytical troubleshooting and technical support for routine and non-routine testing.
• Evaluate and implement method improvements or optimizations to enhance method performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level