An amazing opportunity has arisen for a Quality Control Stability Analyst within the Laboratory Operations team of a Meath based biopharma multinational. The successful candidate will be responsible for Quality Control Stability and associated laboratory activities.
· Support activities including general lab readiness, audit readiness in compliance with GMP requirements.
· Contribute to a continuous improvement environment and bring problem solving and troubleshooting capabilities.
· Author, Review and Approve Stability Protocols and Stability Reports
· Develop and enroll Stability Programs on LIMS
· Perform stability pulls as per Stability schedule
· Aliquot stability pulls in a timely manner and deliver to the relevant testing Laboratory
· Collate stability data in relevant stability reports
· Perform trending in a timely manner
· Assist in laboratory investigations as appropriate
Qualifications and Experience
· Degree qualification (Science/Quality/Technical).
· 2-4 years experience in the biotechnology and/or pharmaceutical industry.
· Preferably Lean Six Sigma experience.
· Ability to think logically and be proactive under pressure.
· Ability to work as part of a team and on own initiative in a constructive manner.
· Flexible and self-motivated.