Excellent contract opportunity for a QC Analyst currently working within sample management (QCSM) who is looking to climb the ladder in this area into a more senior position or a fantastic opportunity for someone who has transferrable skills and experience from managing stability projects or scheduling lab operations in order to proces samples efficiently within a GMP environment.
** 12 month contract with the possibility of extension.
Tops Skills:
- Previous GMP experience in GMP environment with sampling process & handling.
- A degree of ability to self-schedule and coordinate schedules based on the prioritises of the wider team.
- Experience using electronic systems, for example, LIMS or ERPS (which is SAP) (Enterprise Resource Planning System).
- Important to outline that this is a senior position, so we would be looking for approx. 3 to 5 years of experience in a similar level role.
Duties include:
- Execute sample management activities across the site - sample distribution, LIMS logging, shipment receipt
- Perform Stability Program related activities such as pulling stability samples, study initiations.
- Create/own and approve protocols, sample plans., SOPs, training manuals.
- Perform SAP, LIMS and CIMS functions/ transactions within the sample management remit
- Out of hours responder for sample management equipment (fridges /freezers / incubators)
- Responsible for their own training and safety compliance.
- Sample shipments and temperature monitoring activities.
- LIMS data coordination of commercial and import batches
- Management and maintenance of the Site Inventory of Reference Standards, Assay Controls, Training and Verification samples.
- QC Representative for NPI activities and routine Product meetings as required.
Job Summary:
- Under minimal supervision, responsible for one or more of the following activities in QC including sample and data management and equipment maintenance.
- Contributes to team by ensuring the quality of the tasks/services provided by self
- Contributes to the completion of milestones associated with specific projects or activities within team
- This role will support QC and manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.
Specific Job Duties:
- Liaise with site Planning, Manufacturing and Inspection regarding 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 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.
