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