Bioassay Analyst (Min. 2 Years Exp.)

Careerwise Recruitment

Munster, Cork

QC Analyst - Bioassay - 18 month contract - Days role. THE ROLE: This position is responsible for carrying out tasks and projects related to raw material, utility, in process, release and stability testing of biotechnology products as required by Good Manufacturing Practice (GMP. GENERAL SCOPE OF RESPONSIBILITIES: * Achieves a high level of competency in laboratory methods and procedures to support raw material, utility, in process, release and stability testing of biotechnology products. * Performs routine and non-routine Microbiological and or Biochemical/Chemical testing activities as required. * 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 and Manufacturing personnel 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. * Initiates and drives change controls to completion to implement process improvements. * Actively participates in lean initiatives such as Kaizen, 5S 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. SPECIFIC TESTING EXPERIENCE REQUIRED. * Initiation and Maintenance of Mammalian Cell Lines. * Cell Culture Based Bioactivity Testing. * ELIZA Testing. * qPCR Testing. * Bioburden. * Endotoxin. * Environmental Monitoring. * Microbial Identification. OTHER RESPONSIBILITIES / DETAILED DUTIES MAY APPLY: * Deputises for the QC Team Leader as appropriate. * Maintains and develops knowledge of analytical technology as well as cGMP standards. * Partners with other departments to ensure that all QC testing activities are completed in a compliant and efficient manner. 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 Michael Hanrahan today for further information on 021-2019817 or email: mhanrahan@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. This job originally appeared on RecruitIreland.com.

2072 days ago