LSC have a great contract opportunity for a QA Specialist to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life.
If you have 3+ years QA experience supporting lab operations this could be your next career move.
ABOUT THE ROLE
Reporting to the Senior Manager, QA Laboratory Operations the QA Senior Specialist will support the development and implementation of the QA activities related to QC laboratory operations and QC site operations. The role will support the centralized EU based Global Biologics Laboratory performing commercial finished product testing and release activities. The QA Senior Specialist will also provide quality oversight for internal equipment qualification, method transfer activities, and QC site operations for the manufacture of biologics drug substance.
Primary responsibilities
- Perform critical QA review and approval activities for laboratory investigations, deviations, and associated corrective actions
- Oversee contract testing laboratories investigations and documentation
- Review and approve operational SOPs, test methods, forms, and directives
- Contribute to annual product reviews and trending reports
- Support laboratory equipment/instrument qualification protocols and reports
- Assist in method validations and technical transfers
- Collaborate on establishing best practices and continuous improvement initiatives
- Support QC laboratory through global regulatory agency inspections
- Participate in the execution of the internal audit program
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- BSc in Science or related discipline
- Minimum 3 years of Quality experience in the biopharmaceutical industry
- Thorough understanding of cGMP requirements for laboratory compliance
- Excellent written and verbal communication skills
- Strong initiative and ability to work both independently and as part of a team
- Exceptional time management and organizational skills
- Proven ability to multi-task and work across a team matrix
Apply via this advert or contact Kathy Gillen on 021 47718212 if you have any more questions about this role!
As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply. LSC do not provide work permits or visas.
