Validation Specialist-Methods Transfer
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QRC Group, LLC
Aibonito
Summary
The Validation Specialist is responsible for planning, executing, and documenting analytical method transfers, validations, and verifications. They ensure that analytical methods are robust, reproducible, and compliant with regulatory requirements across laboratories.
Job Description
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.
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)
QRC group is a life science firm dedicated to provide services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Our services and solutions include:
Process and Laboratory Investigation
• Corrective and Preventive Action (CAPA)
• Change Control
• Training
• Document Management Control
• QA Laboratory
• Methodology Transfer and Validation
• Instrument Calibration
• Validation and Training in Chromatographic Data Acquisition System
• Cleaning Validation
• Automation Engineering
• Quality Systems
Founded
2005
Company size
51-200 employees
Industry
Staffing and Recruiting
Org type
Privately Held
Headquarters
Caguas, PR
QRC group is a life science firm dedicated to provide services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Our services and solutions include:
Process and Laboratory Investigation
• Corrective and Preventive Action (CAPA)
• Change Control
• Training
• Document Management Control
• QA Laboratory
• Methodology Transfer and Validation
• Instrument Calibration
• Validation and Training in Chromatographic Data Acquisition System
• Cleaning Validation
• Automation Engineering
• Quality Systems
Founded
2005
Company size
51-200 employees
Industry
Staffing and Recruiting
Org type
Privately Held
Headquarters
Caguas, PR