Cpl, in partnership with our client Pfizer, are currently recruiting for QC Sample Management Analysts to join the team in their Biologics facility in Grange Castle, Dublin West.
Responsible for carrying out sample management tasks pertaining to GC / external site manufactured products, regulatory reserve samples, stability samples and Board of Health samples.
- Routinely receive manufacturing test samples and distribute them to the appropriate analytical laboratories.
- Perform scheduled and non-scheduled sample pulls as per Stability Protocols, and distribute the samples to the appropriate analytical laboratories.
- Enrol stability batches onto the Stability Program.
- Oversee and maintain appropriate procedures to ensure chain of custody for QC samples is maintained.
- Use of Laboratory Information Management System (LIMS) for sample tracking.
- Manage the incoming shipment processes from external sites; verification of sample inventory, processing of samples and distribution to QC test laboratories.
- Delivery of ID / tailgate samples for shipment out with bulk drug substance.
- Reference material inventory management.
- Partner closely with customers and stake-holders to understand and deliver samples within specified turn-around times and escalate when necessary.
- Ensure a high level of customer service for teams submitting samples for QC.
- Management of ad-hoc sample request procedure and distribution of the associated samples to the appropriate analytical laboratories.
- Disposal of batch back-up / contingency samples post disposition and release to market.
- Disposal of remaining stability study samples (including overage) post study completion.
- Support the QCSM investigation process by providing accurate and concise information in a timely manner and raising investigations in QTS.
- Participate in cross functional teams as required to provide support on and resolution of sample management related issues.
- Maintain the QCSM laboratories in a state of audit readiness at all times.
- Participate in new initiatives such as the 5S, Standard Work, Data Integrity and IMEX programs as they arise.
- Participate in and drive the continuous improvement of all aspects of the QCSM group.
- Ensure compliance with cGMP, corporate standards / Pfizer Quality System (PQS), site policies / procedures, and regulatory requirements.
Education / Experience:
- Third level Qualification in Science, Engineering or equivalent is preferred, though not essential.
- Exceptions may be considered where relevant skills/experience and correct attitude and behaviours exist (this may be supplemented by further education in parallel).
- Excellent communication and interpersonal skills.
- An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
Interested applicants should apply with CV.