Job Description

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

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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.

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Responsibilities:

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

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- Strong background in microbiology and biochemistry.
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- Experience with plate readers and associated software is a plus.
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- Ability to troubleshoot and resolve technical issues effectively.
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- Familiarity with regulatory requirements and quality systems (e.g., CAPA, Change Control).
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- Strong project management and coordination skills.
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- Excellent communication and collaboration abilities.
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By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy.

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📌 QC Validation Specialist (Microbiology & Biochem) (Victoria)
🏢 Proclinical Group
📍 Victoria