Testing Coordinator

3 weeks ago

Melbourne, Australia CSL Behring Full time

**The Opportunity**:
CSL Ltd. is looking for a **Testing Services Coordinator** to join our Building Operations & Services team on an **18-month fixed term contract**. You will be based at our Melbourne office.

Reporting to the Associate Director, Building Operations & Services, you will manage a team of people to deliver Quality Control (QC) testing outcomes in agreement with EHS and GxP principles. You will ensure that the work of your team is executed and delivered precisely and that the completed work satisfies the relevant Regulator and Quality requirements.

This role will also include the management of labour hire service provider, who will provide the labour to support the CSL Melbourne facility. This includes managing the work authorisation / scope of work contractual requirements, monitor and report on KPIs, manage and report budget and variations.

**The Role**:

- Operational oversight and directing the Quality Control activities for Operational oversight and directing the Quality Control activities for Sample Testing - including Environmental Monitoring (EM) and Critical Utilities (CU); Sample Management; Microbiology functions (plate reading/Sample Preparation) / Logistics & QSD; LIMS Data Entry; Raw Material Testing and Coordinate Off-site Sampling Management
- Manage service provider contract, reports on KPIs and budget
- Provide daily oversight of staff completing environmental and critical utility sampling and monitoring
- Manage testing schedule for Testing Services team for CSL Melbourne
- Evaluate performance of analytical instruments and equipment and recommend new acquisition or replacements
- Ensure laboratory instruments are qualified, calibrated and maintained and documentation comply with cGMP standards
- Help develop new methods and procedures and maintain standard operating procedures (SOPs)
- Document quality issues and performance measures for management review
- Lead deviation investigations for OOS and ensure prompt completion of corrective and preventive actions (CAPA).
- Provide testing quality compliance metrics for reporting to senior leadership
- Initiate and execute change controls
- Identify and communicate all issues regarding the EM/CU program's that may cause a delay to service performance

**NOTE** - Flexibility with work hours as some weekend and overtime may be required.

**Your skills and experience**:

- Bachelor's degree in a relevant scientific discipline (Biology, Microbiology, Chemistry, etc.)
- 2+ years of laboratory experience
- Background in Quality Control (QC) will be highly valued
- Demonstrated experience in project work
- Excellent knowledge of GLP, GMP and ICH guidelines
- Knowledge of change control and deviation management, including being experienced in technical writing
- Knowledge of stability trials, monitoring of critical utilities, environmental monitoring and analytical method validation
- Stakeholder relationship and management
- Excellent employee management skills

**How to Apply**

**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

**About CSL**:
CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL.

**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL**:

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