Job Title: QC Separations Analyst
This position is responsible for carrying out tasks and projects related to testing procedures, equipment and lab utilities as required by Good Manufacturing Practice (GMP).
Responsibilities:
* 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 its associated software.
* Writes/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.
* 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 provides 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.
Requirements:
* 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.
Technical Skills:
* HPLC
* Capillary Electrophoresis
* UPLC/Mass Spec (desirable)
* LIMS
* Trackwise
* Electronic documentation systems
* Microsoft Office applications such as word, Excel, PowerPoint