Methods Transfer - Validation Specialist

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

Benefits offered by this job

Learning & development

Collaborative environment

Impactful projects

Job summary

QRC Group, LLC is seeking a Validation Specialist to plan, execute, and document analytical method transfers, validations, verifications, and improvements in compliance with regulatory requirements. The role collaborates with QC, R&D, Manufacturing, and external labs to support product lifecycle and submissions.

The candidate will develop validation strategies per ICH, FDA, EMA, USP guidelines, draft validation protocols, perform statistical analyses, and ensure robust, traceable

Qualifications

• 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.

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.

Skills

Technical writing

Analytical development/quality control

Method transfers & validations

Education

Bachelor’s or Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline

Job description

Methods Transfer - Validation Specialist

• Contract

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

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.

Key Responsibilities

Method Transfer

• 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.

Analytical Support

• 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.
• 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.

What We Offer

• Opportunities for learning, development, and professional growth.
• A collaborative and supportive work environment.
• The opportunity to work with industry-leading clients on impactful projects.

Your information will be kept confidential according to EEO guidelines.