Initial 12-month contract role.
Can be a day’s role or shift role, depending on your preference. (Shift +20%)
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). Partners with other Departments to ensure that all QC testing activities are completed in an efficient manner.
GENERAL SCOPE OF 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 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.
SPECIFIC TESTING EXPERIENCE REQUIRED
- Capillary Electrophoresis
- UPLC/Mass Spec (desirable)
KEY COMPETENCIES REQUIRED
- Excellent interpersonal skills
- Ability to operate as part of a team is critical.
- Excellent communication skills both written and verbal.
- Good knowledge of LIMS, Trackwise and Electronic documentation systems.
- Good knowledge of Microsoft Office applications such as word, Excel, PowerPoint
- Experience working in a high throughput laboratory environment.
- Excellent technical writing skills.
- Attention to detail.
- Strong problem-solving skills.
- Results and performance driven.
QUALIFICATIONS AND EXPERIENCE
- BSc (Honours) 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
The role will be part of a team of 22 analysts
- IEX- HPLC
- Reverse Phase HPLC
- Mass Spec