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Validation Specialist-Methods Transfer

QRC Group
Posted a month ago, valid for 11 days
Location

Aibonito, PR, US

Salary

Competitive

Contract type

Contract

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Sonic Summary

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  • The Methods Transfer - Validation Specialist is tasked with planning, executing, and documenting analytical method transfers and validations in compliance with regulatory standards.
  • The role ensures that analytical methods are robust and suitable for use in both internal and external laboratories.
  • Candidates must possess a Bachelor’s or Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
  • A minimum of five years of experience in a regulated industry such as pharmaceuticals, biotech, or medical devices is required, along with experience in method transfers and validations.
  • The position may offer a competitive salary, and candidates should also have strong technical writing skills and be bilingual in Spanish and English.
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)





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