QC Sample Management Analyst (QCSM)
Dublin 22, Grange Castle
Job Purpose
Responsibility for carrying out sample management tasks pertaining to GC and external site manufactured products, regulatory reserve, stability, and Board of Health samples.
Job Responsibilities
- Routinely receive manufacturing test samples and distribute to the appropriate analytical laboratories.
- Oversee and maintain appropriate procedures to ensure chain of custody for QC samples is maintained.
- Manage the incoming shipment processes from external sites, verification of sample inventory, processing of samples and distribution to QC test laboratories.
- Shipment of Drug Product and associated bulk Drug Substance regulatory samples to BOH sites.
- Management of stability sample processes including study enrolment, time-point pulls, sample shipment, and study disposal.
- Maintenance of the reserve program, including inspection of reserve and retention samples, documentation of inspection results, and maintenance of reserve/retention equipment.
- Reference material inventory management.
- Perform review and approval of QCSM standard operating procedures, sampling and analysis plans, and stability protocols to ensure compliance.
- Facilitate laboratory investigations and support associated product investigations.
- Support the preparation and review of QC APQR and periodic review reports.
- Partner closely and proactively engage with customers and key stakeholders to understand and deliver samples within specified turnaround times, participating in cross-functional teams as required.
- Represent QCSM at product, technical and robustness team meetings and lead/drive associated deliverables.
- Contribute to the completion of complex projects, managing own time to meet agreed targets and developing plans for work activities on own projects within a team.
- Participate in new initiatives such as the 5S, Standard Work, Data Integrity and IMEX programs as they arise.
- Engage with the business to identify and define scope for continuous improvement, robustness, and Best Practice initiatives assisting with improving the efficiency of local and across-site processes and procedures.
- Ensure compliance with cGMP, corporate standards/Pfizer Quality System (PQS), site policies/procedures, and regulatory requirements.
- Technical writing assignments such as SOPs, trend reports, risk assessments, laboratory investigations, and change controls.
- Assist in the maintenance and development of training programs and perform training of other analysts.