Analytical Methods Transfer & Validation Specialist

QRC Group, Inc; Aibonito (PR); In loco; USD 90.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Learning & development

Collaborative environment

Impactful projects

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Technical writing

Analytical development/quality control

Method transfers & validations

Formazione

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

Descrizione del lavoro

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