Cache of job #14072823

Job Title

Snr QC Associate (Bioanalytical)

Employer

CAREERWISE RECRUITMENT

Location

DUBLIN

Description

SNR QC ASSOCIATE (BIOANALYTICAL SCIENCES) required by CareerWise for our BioTech client in South County Dublin, initial 12 month contract on offer. The SNR QC ASSOCIATE (BIOANALYTICAL SCIENCES) will have experience in Bioassays, Immunoassays and Cell Culture and will have 4-5 years of experience in a GMP Laboratory. THE ROLE: * Experience in a wide variety of analytical techniques including but not limited to cell based- Bioassays, Immunoassays, Cell Culture (use of cells to execute bioassays) and Aseptic Technique. Experience with liquid-handling robots is also preferable. * Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays. * Participate in the peer review of analytical data. * Responsible for providing technical guidance and applying expertise and critical thinking to help to resolve technical issues. * Lead training of staff on technical aspects of job as required. * Develop, revise and implement procedures that comply with appropriate regulatory requirements. * Qualification of analytical equipment and related testing functions. * Participate in Analytical Method Transfers. * Compliance with Standard Operating Procedures and Registered specifications. * Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP. * Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures. * Participate in the generation and update of SOP's, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications. * Participate in regulatory agency inspections as required. * Plan and implement procedures and systems to maximise operating efficiency. * Manage and contribute to the achievements of department productivity and quality goals. REQUIREMENTS: * Experience with TrackWise, Change Control Systems, EDMQ and SAP an advantage. * Experience with Regulatory inspections and interaction with inspectors is preferable. * Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline. * Have 4-5 years of experience in a pharmaceutical/healthcare Laboratory. * Experience in Bioassays, Immunoassays and Cell Culture is essential. * Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.

Date Added

1626 days ago

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