QC analyst - seperations

• Achieves a high level of competency in laboratory methods and procedures to support in process and release testing of biotechnology products.
• Review and approval of laboratory test results.
• Performs analytical testing activities in relation to method validation and technical transfer activities to ensure that all methods meet ICH, USP and EP guidelines.
• Executes validation, operation, maintenance, calibration and troubleshooting of equipment and it's associated software.
• Write/executes reports and reviews IQ/OQ and PQ protocols to ensure that all relevant equipment is qualified for cGMP use.
• Ensures that all testing is completed, reviewed and approved within agreed turnaround times.
• Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.
• Trains other QC analysts in laboratory methods and procedures when required.
• Writes/updates and reviews TMs, SOPs and WIs as required.
• Writes and reviews invalid assays, non-conformances and deviations as required.
• Actively participates in JSI lean initiatives such as Kaizen, 6S and Gemba.
• Is an active member of the QC group and provide assistance with other group activities as required.
• Communicates relevant issues to the QC Team Leader promptly.
• Maintains and develops knowledge of analytical technology as well as cGMP standards.

• HPLC
• Capillary Electrophoresis
• UPLC/Mass Spec (desirable)

• BSc (Honors) in a scientific/technical discipline.
• A minimum of 2 years' experience in a QC laboratory-testing environment within the biological and/or pharmaceutical industry.
• Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory

Berkley Group