Senior Associate QC (QC Sample Management)
Life Science Recruitment View all jobs
- Dublin
- Contract
- Full-time
- Liaise with site Planning, Manufacturing and Inspection regarding ADL manufacturing schedule and required QC testing.
- Liaise with Stability Product Representatives and Product Quality Leads as required.
- Perform routine sample management tasks as per procedures.
- With a high degree of technical flexibility, work across diverse areas within QC
- Plan and perform multiple, complex routine/ non-routine tasks with efficiency and accuracy.
- Report, evaluate, back-up/archive, trend and approve data.
- Troubleshoot, solve problems and communicate with stakeholders.
- Initiate and/or implement changes in controlled documents and equipment.
- Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
- Operate and maintain GMP equipment, including responding and management of GMP alarms.
- Introduce new techniques/ Processes to the area, where appropriate.
- Evaluate sample management practices for compliance and operational excellence improvement on a continuous basis.
- LIMS data coordination of commercial and import testing lots where applicable
- LIMS lot logging for ADL manufactured lots.
- Provide technical guidance, may contribute to regulatory filings.
- Represent the department/organization on various teams as required. Train others.
- Interact with outside resources.
- Perform general housekeeping in all sample management areas in line with 5S.
- Bachelor’s degree in a Science related field is required.
- 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, where 2 – 3 years of specific sample management/ stability programme experience is desirable.
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.