Methods Transfer - Validation Specialist at QRC Group, Inc

Añasco, , Puerto Rico -

Full Time

Start Date

Immediate

Expiry Date

24 Jun, 26

Salary

0.0

Posted On

27 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Method Transfer, Method Validation, Method Verification, Method Improvement, Protocol Preparation, Report Preparation, Technical Training, Troubleshooting, ICH Guidelines, FDA Guidelines, EMA Guidelines, USP Guidelines, Statistical Data Analysis, Technical Writing, Analytical Troubleshooting, Bilingual (Spanish/English)

Industry

Staffing and Recruiting

Description

Company Description QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields. Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions! 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. 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. Method Validation & Verification 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. Qualifications 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) Additional Information Benefits 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.

Responsibilities

The specialist plans, executes, and documents analytical method transfers, validations, verifications, and method improvement initiatives to ensure methods are robust and suitable for intended use. This involves coordinating transfers between laboratories and preparing necessary protocols and reports in compliance with regulatory requirements.