Analytical Method Validation Specialist

3 weeks ago


St Louis MO USA, United States Mallinckrodt Pharmaceuticals Full time
Job Title

Analytical Method Validation Specialist

Job Summary

The Analytical Method Validation Specialist is responsible for conducting comprehensive reviews of analytical methods to ensure compliance with regulatory standards and suitability for intended use. This role is critical in maintaining product quality and minimizing risk associated with analytical processes.

Key Responsibilities
  • Conduct in-depth reviews of analytical method validation protocols, procedures, and associated data.
  • Assess method performance against established acceptance criteria for parameters such as accuracy, precision, specificity, linearity, range, limit of detection, and limit of quantification.
  • Evaluate method robustness and ensure compliance with relevant regulatory guidelines (e.g., USP, Ph. Eur., ICH).
  • Prepare detailed reviewed reports summarizing findings, conclusions, and recommendations.
  • Participate in closure meetings with stakeholders to discuss review outcomes and gain approval.
  • Maintain accurate and organized documentation of review activities and findings.
  • Collaborate with cross-functional teams to address validation-related issues and implement corrective actions.
  • Stay updated on relevant regulatory requirements and industry best practices.
Requirements
  • BS in Chemistry, Chemical Engineering, or related science or equivalent combination of education, experience, and competencies.
  • Minimum of 5 years' of pharmaceutical experience required with prior experience in analytical method validation and quality assurance experience.
  • Strong understanding of analytical chemistry principles and techniques.
  • Knowledge of pharmaceutical regulations including current GxP, GAMP5, Part 11, and Data Integrity requirements.
  • Knowledge of ICH Q7 and Q11 is required.
Preferred Skills
  • Excellent written and oral communication skills.
  • Proficiency in data analysis and interpretation.
  • Ability to work independently and as part of a team.
  • Understanding of basic statistical principles.
  • Complete understanding and application of principles, concepts, practices, and standards within discipline.
  • Knowledge of US and International pharmaceutical manufacturing regulations.
Work Environment

40-60% Office environment which includes sitting for long periods of time and computer use.

10-20% Manufacturing environment exposure to temperature, noise, chemical or potent compound exposure.



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