Initial 12-month contract onsite role.
4 cycle shift @ 33%: 12-hour shifts (7-7); 2 days, 2 nights, 4 days off
This position is responsible for carrying out tasks and projects related to equipment, lab utilities and testing procedures as required by Good Manufacturing Practice (GMP). Partners with other Departments to ensure that all QC testing activities are completed in an efficient manner.
Key analytical technique required: HPLC and experience with troubleshooting instrumentation/method issues.
Other desirable techniques: A280 UV Vis, Solo VPE, Nephelometry testing, Raw materials testing – Density, FTIR), residual protein assay, TOC analysis, Wet Chemistry, Verification Sampling, Sample Management
- Achieves competency in laboratory methods and procedures.
- Trains other QC analysts in laboratory methods and procedures when required.
- 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.
- Performs routine and non-routine analytical testing activities.
- Review and approval (where appropriate) of laboratory test results.
- Ensures that testing and results approval are completed within agreed turnaround times.
- Writes and reviews laboratory TMs, SOPs and WIs as directed by company policy.
- Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.
- Is an active member of the QC group and provide assistance with other group activities as required and communicates relevant issues to the QC Team Leader and Manager.
- Deals with non-conformances/ deviations in an accurate and timely manner.
- Deputizes for the QC Team Leader as appropriate.
- Maintains and develops knowledge of analytical technology as well as cGMP standards.
- In process control testing and activities to support the production Units
- Liaisons with Operations department regularly throughout the day to ensure testing activities are completed in an efficient manner and issues rectified
Qualifications and experience
- Minimum of level 8 qualification of a scientific/technical discipline is required.
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
- Minimum of 2yrs previous experience in a similar role.
- Demonstrates ability to work with teams and individuals
- Asserts personal ideas and opinions using persuasion to influence others
- Seeks opportunities to grow and develop professionally
- Uses best practices to improve business operations
- Holds self-accountable for compliant and flawless execution
- Works effectively with people that have diverse styles, talents and ideas
- Maintains the highest standards of ethical behaviour
- Treats people with dignity and respect
QC testing knowledge
• Protein Concentration by UV Vis Spectrophotometry • HPLC analysis using Empower 3 • Cleaning Validation by Total Organic Carbon testing • IgG testing by Nephelometry • Compendial tests: pH, colour, appearance, density, FTIR