Sr Associate Qc

5 days ago

County Dublin, Ireland Recruitment By Aphex Group Full time

This is a 12-month initial contract.
Purpose 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.
Responsibilities 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.
Liaise with site Planning, Manufacturing and Inspection regarding ADL 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.
Primary knowledge, skills, competencies and relevant experience Knowledge: Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories.
Deepens technical knowledge through exposure and continuous learning Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discover Take initiative to identify and drive continuous improvements Communication skills (verbal and written) at all levels Strong Technical writing skills for GMP documentation (e.g.
investigations, procedures, change controls) Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope Ensures compliance within regulatory environment Develops solutions to technical problems of moderate complexity Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues Interprets generally defined practices and methods Able to use statistical analysis tools to perform data trending and evaluation Project Management and organizational skills, including the ability to follow assignments through to completion Qualifications Bachelors 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.
Skills: LIMS logging Stability Program related activities Technical Writing Skills Biopharmaceutical QC experience Sample Management

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