Senior Associate QC Specialist – BioAnalytical Sciences – REF NHA41

We are currently seeking to recruit a Senior QC Associate to become a key member of the Bioanalytical Sciences team within a leading Dublin based biopharmaceutical multinational.
The successful candidate must have previous experience in bioassays, immunoassays and cell culture.

Key Responsibilities
• 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.
• Develop, revise and implement procedures that comply with appropriate regulatory requirements.
• Qualification of analytical equipment and related testing functions.
• Participate in Analytical Method Transfers
• 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.

Qualifications and Experience:

• 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.
• Excellent written and verbal communication skills
• Experience with TrackWise, Change Control Systems, EDMQ and SAP an advantage
• Knowledge of applicable Regulatory requirements
• Experience with Regulatory inspections and interaction with inspectors is preferable
• Experience leading cross-functional teams
• Experience working with teams and influencing decision.
• Skilled in the use of problem solving tools/techniques
• Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.

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