QC SEPArations Analyst, HPLC (12m, Cork)

CareerWise Recruitment

Cork

We have a number of contract QC SEPARATIONS ANALYST roles with our BioTech client in Cork, these are onsite lab based days roles on initial 12 month contracts. The QC SEPARATIONS ANALYSTS will have a minimum of 2 years' experience in a QC laboratory-testing environment within the biological and/or pharmaceutical industry. Analysis includes: cSDS cIEF SE-HPLC IEX- HPLC Reverse Phase HPLC Mass Spec and knowledge of Empower is the most sought after skill. THE ROLE: * 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. 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. Please call Conor Twomey today for further information on 087-0907204 or email: ctwomey@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

400 days ago