Job Reference: JO-2305-66453_1685010729
We have an exciting QC opportunity for a Analyst in Separations to join a busy team in a large Biotechnology company. This individual will be responsible for carrying out tasks and projects related to Separations analysis of biotechnology products as required by Good Manufacturing practice (GMP). The individual will participate in the delivery of lab testing efforts by using both existing and new procedures or processes to independently interpret data and identify and correct issues. You will partner with other Departments to ensure that all QC testing activities are completed in an efficient manner.
- 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.
- 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
- Testing experience required HPLC, Csds, cIEF, SE-HPLC, IEX- HPLC, Reverse Phase HPLC And Mass Spec
- Excellent interpersonal skills.
SPECIFIC TESTING EXPERIENCE REQUIRED
- Capillary Electrophoresis
- UPLC/Mass Spec (desirable)
This role might be for you if:
- You thrive in a multifaceted and fast-paced environment.
- You possess excellent verbal and written communication skills.
- You possess a strong analytical ability and enjoy problem solving.
- You demonstrate an ability to work within a successful team.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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