Senior Endotoxin Testing Specialist
Quantum HR Indonesia · United Arab Emirates
Tailor my CV for this job — freeThe role focuses on endotoxin testing strategies, method suitability, validation, investigation, data review, and compliance with applicable pharmacopeial and regulatory requirements. Working remotely, the specialist will collaborate with quality control, quality assurance, microbiology, manufacturing, and regulatory teams to support reliable testing practices and robust quality decisions.Key ResponsibilitiesProvide technical guidance on bacterial endotoxin testing programs for pharmaceutical products, components, raw materials, and relevant medical devices.Oversee the development, assessment, and implementation of suitable endotoxin testing methods.Review testing approaches based on applicable pharmacopeial requirements, including USP and European Pharmacopoeia standards.Provide technical oversight of Limulus Amebocyte Lysate (LAL) testing methodologies, including gel-clot, chromogenic, and turbidimetric techniques.Assess the suitability and application of recombinant factor C (rFC) methods where appropriate.Review method suitability studies, including inhibition and enhancement testing.Evaluate endotoxin limits, maximum valid dilution calculations, and test acceptance criteria.Review analytical protocols, validation plans, verification reports, and method transfer documentation.Assess laboratory data, standard curves, positive product controls, negative controls, and system suitability results.Provide technical guidance on endotoxin recovery, interference, dilution strategies, and analytical troubleshooting.Review out-of-specification, out-of-trend, and atypical endotoxin test results.Support root cause investigations involving contamination risks, testing discrepancies, and potential laboratory errors.Evaluate endotoxin control strategies across manufacturing, water systems, raw materials, equipment, and production environments.Review laboratory procedures, sampling plans, test records, and controlled documentation for completeness and compliance.Collaborate with microbiology, quality control, quality assurance, manufacturing, validation, and regulatory affairs teams.Support risk assessments involving bacterial endotoxin contamination and product safety considerations.Monitor changes in relevant pharmacopeial chapters, regulatory guidance, and industry practices.Recommend improvements to testing procedures, laboratory controls, documentation, and data integrity practices.Contribute to internal audits, inspection readiness, technical assessments, and continuous improvement initiatives.Prepare technical reports, trend analyses, and management summaries relating to endotoxin testing performance.Qualifications and ExperienceBachelor's or master's degree in Microbiology, Pharmaceutical Sciences, Biotechnology, Biochemistry, Chemistry, or a related discipline.Significant experience in pharmaceutical microbiology, bacterial endotoxin testing, or quality control laboratory operations.Strong knowledge of bacterial endotoxin testing principles and relevant pharmacopeial requirements.Practical familiarity with LAL testing methods, including gel-clot, chromogenic, and turbidimetric techniques.Understanding of recombinant factor C testing and its appropriate application.Experience reviewing endotoxin method suitability, validation, verification, and transfer studies.Knowledge of inhibition and enhancement testing and common sources of analytical interference.Ability to assess endotoxin limits, dilution calculations, test controls, and acceptance criteria.Familiarity with USP, European Pharmacopoeia, and applicable regulatory expectations for endotoxin testing.Understanding of GMP, good documentation practices, laboratory quality systems, and data integrity principles.Experience investigating atypical results, out-of-specification findings, and microbiological contamination risks.Knowledge of pharmaceutical water systems, cleanroom environments, sterilization processes, and contamination control principles.Strong analytical skills and the ability to interpret complex laboratory data.Experience preparing and reviewing technical reports, SOPs, validation documents, and investigation records.Strong written and verbal communication skills.Ability to coordinate technical activities and provide specialist guidance in a fully remote environment.What We OfferFully remote working arrangement within the UAE employment framework, subject to applicable eligibility and authorization requirements.Opportunity to contribute to pharmaceutical microbiology, contamination control, and product quality programs.Collaboration with multidisciplinary laboratory, manufacturing, quality, and regulatory professionals.Professional development in endotoxin testing technologies, analytical quality systems, and regulatory compliance.A senior technical role with opportunities to improve testing reliability and laboratory performance.How to ApplyInterested candidates should submit an updated CV highlighting their endotoxin testing experience, LAL or recombinant factor C expertise, method validation background, and pharmaceutical microbiology qualifications.Application Subject: Application – Senior Endotoxin Testing Specialist (UAE Remote)Important Note: This is a fully remote technical oversight and documentation role. Physical laboratory testing, sample preparation, instrument operation, and laboratory handling activities must be performed by appropriately qualified personnel at authorized facilities. The specialist may provide remote technical review, data assessment, method guidance, and investigation support but must not replace required on-site laboratory personnel. Formal laboratory approvals, regulated quality decisions, and regulatory submissions must be completed by appropriately authorized personnel. Candidates should confirm applicable employment arrangements, residency requirements, and work authorization before accepting an offer.