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Qc analyst

Carlow
Morgan Mckinley
Qc analyst
Posted: 31 January
Offer description

QC Analyst*24/7 Shift cycle associated with this role*11 month contract role with potential to extension*GMP Pharmaceutical Industry Experience Required (Research/Academic Experience applicable for this role)As a QC Analyst, you will perform and review a range of laboratory techniques including immunoassays, cell-based potency bioassays, HPLC, and compendial methods. This role supports both routine and non-routine testing, as well as project work, to ensure processes and finished products meet regulatory and quality requirements to enable product release.Reporting to the QC Manager, you will work within a regulated Quality Operations Laboratory, ensuring objectives are met in line with compliance, safety, and reliable supply expectations. The QC function plays a critical role in ensuring materials are manufactured, tested, stored, and released to the highest quality and regulatory standards, working closely with internal teams and external partners.Position ResponsibilitiesPerform laboratory testing and QC activities in accordance with cGMP, cGLP, and site safety requirementsDrive compliance with global quality policies, procedures, and regulatory standards in day-to-day activitiesDevelop, implement, and maintain laboratory procedures in line with regulatory requirementsEnsure daily adherence to Quality Systems within the QC departmentExecute assigned laboratory testing and support activities as part of the QC teamComplete data processing and review activities in a timely and compliant mannerPrepare and complete laboratory investigations, deviations, and reports in line with site proceduresGenerate and support trend data, investigations, nonconformances, validation protocols, and reports related to method validation/verification and equipment qualificationParticipate in daily QC Tier 1 meetings, communicating testing progress, deviations, and prioritiesPeer review testing documentation to ensure data integrity and "Right First Time" performanceWhere applicable, review, approve, and trend test resultsSupport and participate in OOS investigations and root cause analysisProvide support during audits and inspections, acting as auditee for assigned responsibilitiesDrive continuous improvement initiatives, applying root cause analysis tools (e.g. FMEA, Fishbone, 5 Whys)Work collaboratively to promote a safe, compliant, and quality-focused culture on siteCarry out additional duties as required to support laboratory operationsReporting StructureReports to QC ManagerQualifications & ExperienceTechnicalKnowledge of Irish, European, and international regulatory requirementsStrong understanding of cGMP and laboratory quality systemsExperience with laboratory documentation, report writing, and procedural complianceProficiency in Microsoft Office and relevant laboratory computer systemsUnderstanding of Lean / Six Sigma methodologies preferredImmunoassay and cell culture experience highly desirable (1-2 years experience)People & BehaviouralStrong communication and interpersonal skillsAbility to work effectively within cross-functional and highly regulated teamsA proactive mindset with a desire to learn, develop, and continuously improveHigh standards of integrity, accountability, and professionalismAbility to contribute to and support a positive, compliant team cultureEducationBachelor's degree or higher in a science-related discipline preferred

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