QC Validation Specialist (Microbiology & Biochem)

Are you passionate about quality and precision? Join our client with your validation expertise and help ensure top-tier standards every day.

Proclinical is seeking a QC Validation Specialist to support quality control and validation activities within a pharmaceutical or biotechnology setting. In this role, you will act as a subject matter expert (SME) in testing methodologies, troubleshooting technical issues, and driving method improvements. This position involves cross-site coordination, regulatory input, and the development of new testing methods. The role is hybrid, requiring three days in the office.

Responsibilities:

• Maintain compliance with QC method validation lifecycle requirements.
• Lead troubleshooting investigations and resolve technical challenges related to QC test methods.
• Provide SME guidance for method standardization and robustness programs.
• Develop and improve current and new test methods, staying updated on the latest testing technologies.
• Coordinate and execute intra-site method transfers and contribute SME input to regulatory filings and audits.
• Design experiments for projects involving new technologies and processes in QC.
• Manage and oversee Analytical Science and Technology (AST) studies.
• Review validation data, identify trends or deviations, and escalatory concerns to management.
• Plan and manage method validation, development, and transfer activities, influencing QC leadership on improvement strategies.
• Stay informed about industry advancements in methods, equipment, and techniques.
• Identify and implement improvements that positively impact the business.

Key Skills and Requirements:

• Strong background in microbiology and biochemistry.
• Experience with plate readers and associated software is a plus.
• Ability to troubleshoot and resolve technical issues effectively.
• Familiarity with regulatory requirements and quality systems (e.g., CAPA, Change Control).
• Strong project management and coordination skills.
• Excellent communication and collaboration abilities.

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