Senior QC Associate
Senior Associate QC - Sample Management: Sample distribution, LIMS Coordination, QC Shipments, writing SOPs, sample plans.
* Site ownership of Stability programme
* Manage all sample management activities throughout the site
* Create/own and approve protocols, sample plans, SOP and documentation
* Responsible for SAP and LIMS functions/ transactions within the sample management remit
* Site ownership of Reference standards and reserves
* 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 of the Inventory of Reference Standards and assay controls, training and verification samples
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:
* Manage Stability Programme on site and frequent collaboration with global Stability Product Representatives (SPR) or Product Quality Leads (PQL) regarding all stability programme matters.
* Perform routine sample management tasks as per procedures.
* With a high degree of technical flexibility, work across diverse areas within the lab
* Plan and perform routine tasks with efficiency and accuracy.
* Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of tasks.
* Report, evaluate, back-up/archive, trend and approve data.
* Troubleshoot, solve problems and communicate with stakeholders.
* Initiate and/or implement changes in controlled documents.
* Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
* Write protocols and perform validation and equipment qualification/ verification. Operate and maintain specialised equipment.
* 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 on site where applicable
* May provide technical guidance. May contribute to regulatory filings.
* May represent the department/organization on various teams. May train others.
* May interact with outside resources.
* Perform general housekeeping in all sample management areas.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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