QC Senior Bioassay Specialist
Job Description. An exciting opportunity has arisen for a QC Senior Bioassay Specialist in our site in Carlow. You will be responsible for coordinating QO Laboratory activities relating to Lab start up, method transfer and product testing work. This is a senior position where you will work with key stakeholders within the business. What you will do: Bring energy, knowledge, innovation and leadership to carry out the following: Participate in the method transfer and or validation of analytical techniques including ELISA, Bioassay, Immunoassay Cell Culture and Cell Based Assays. Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays. Provide technical guidance and apply expertise and critical thinking to help to resolve technical issues. Direct training of junior team members on technical aspects of the role. Develop, revise and implement procedures that comply with appropriate regulatory requirements. Qualification of analytical equipment and related testing functions. Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP. Ensure timely completion of Laboratory Investigation Reports and deviations. Participate in the generation and update of SOP’s, trend data, investigations, nonconformances, validation protocols, reports, method validation/verifications and equipment qualifications. Provide support with audit/inspection requirements to ensure department compliance/readiness. Apply Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions. What skills you will need: In order to excel in this role, you will more than likely have: 5 years of experience in a similar role within the pharmaceutical industry. A relevant master’s in science or other relevant area is desired. Experience in Laboratory ELISA/ Bioassay method transfers, validations and investigations essential. Experience in SoftMax Pro software is desirable. Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices. Ability to mentor lab analysts. Collaborate effectively with analytical partners in the network. Knowledge of relevant GMP and Data Integrity standards. As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. So, if you are ready to: Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.
18 days ago