A great contract opportunity for an experienced QC Sample Management Analyst with a strong background managing large numbers of samples within a busy GMP lab.
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 on rotation within the team 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 the 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 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.
Seniority level
Associate
Employment type
Contract
Job function
Science
Industries
Pharmaceutical Manufacturing
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