Analytical Method Validation Specialist

4 days ago


St Louis, Missouri, United States Mallinckrodt Pharmaceuticals Full time
Job Title: Analytical Method Validation Specialist

Mallinckrodt Pharmaceuticals is seeking a highly skilled Analytical Method Validation Specialist to join our team. As a key member of our quality assurance team, you will be responsible for conducting comprehensive reviews of analytical methods to ensure compliance with regulatory standards and suitability for intended use.

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.
Requirements:
  • BS in Chemistry, Chemical Engineering, or related science.
  • Minimum of 5 years' pharmaceutical experience with prior experience in analytical method validation and quality assurance.
  • 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.
About Mallinckrodt:

Mallinckrodt Pharmaceuticals is a leading global specialty pharmaceutical company that develops, manufactures, and markets specialty pharmaceutical products and therapies. We are committed to making quality products that impact patient lives.

We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and detail-oriented individual with a passion for analytical method validation, we encourage you to apply for this exciting opportunity.



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