Job Description

Under minimal supervision, responsible for one or more of the following activities in QC including sample and data management and equipment maintenance.
• Execute sample management activities across the site – sample distribution, LIMS logging
• 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 logging + data coordination of commercial and import batches.
• Management and maintenance of the site inventory of Reference Standards, Assay Controls, Training and Verification samples within an electronic management system
• 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 ADL manufacturing schedule to establish 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.


Requirements

Relevant experience:
• Bachelor’s degree in a Science related field is required.
• 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, where 2 – 3 years of specific sample management/ stability programme experience is desirable.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products

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