This tremendous opportunity will be part of the Bioassay team responsible for qualifying the Bioassay analytical lab and the transfer of Bioassay analytical methods. This person will be key in the layout of the lab testing to ensure the process is streamlined and in line with site lean methodologies.
This Dublin based role offers excellent opportunity to advance your career within other areas as the project progresses
Activities within the role
· Perform activities for general lab readiness, laboratory equipment qualification and method transfers.
· Strong knowledge and experience of Bioassay methods.
· Perform and carry out a variety of analytical techniques including but not limited to Potency Elisa test in compliance with GMP requirements.
· Follow up-to-date analytical practices with reference specifications, regulations and industry standards.
· Receive and manage samples that come into the lab for stability, in-process and release testing.
· Writing and update of SOPs.
· Cleaning and routine equipment maintenance.
· Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
· Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations
· Participate and comply with Quality Management System requirements.
Qualifications & Experience
· 3 years minimum industry experience with significant knowledge and experience working in a QC laboratory testing environment within the biological and/or pharmaceutical industry.
· Degree qualification (Science/Quality/Technical).
· Preference Lean Six Sigma
· Good verbal and written communication skills
· Excellent troubleshooting and problem-solving skills
· Good attention to detail
· Ability to think logically and be proactive.
· Ability to work as part of a team and on own initiative in a constructive manner
· Flexible and self-motivated
· Experience in Potency, Residual protein A and HCP Elisa method.
· Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory
· Good working knowledge of QC Systems (SoftMax Pro, Gen5, EN, LIMS) and Trackwise