Get AI-powered advice on this job and more exclusive features.PurposeThe QC Analyst (Controls and Standards) is responsible for managing laboratory standards, controls, and critical reagents, ensuring compliance with regulatory requirements and supporting audit readiness. This role plays a key part in maintaining quality systems, facilitating inter-site qualification, and driving continuous improvement in QC operations while upholding cGMP standards.ResponsibilitiesManagement of standards, controls and critical reagents in the QC laboratorySupport with inter-site qualification and extension of controls and standardsProviding audit support to the QC team including performing routine and pre-audit walkthroughs, assisting SMEs to prepare and coordination of QC requests during auditsReviewing and updating QC procedures and processes to ensure compliance to current and updated requirements and regulations e.g. new or updated pharmacopoeia chaptersPreparation of qualification memos in Veeva to support QC testing activitiesUpdate the QC Team Leader on potential problems and highlight improvements where possible by use of the normal communication meansEnsure compliance to cGMP at all timesQualificationsBachelor’s degree (or equivalent) in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Science)Previous experience in a QC laboratory within the pharmaceutical or biotech industryStrong understanding of cGMP requirements and regulatory guidelinesExperience with laboratory standards, controls, and qualification processesFamiliarity with quality systems and electronic systems (e.g., Veeva) is an advantageStrong communication and organizational skills, with the ability to support audits effectivelyAttention to detail and ability to identify and escalate potential issues promptlySeniority levelEntry levelEmployment typeContractJob functionQuality AssuranceIndustriesPharmaceutical Manufacturing
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