Accepts and processes incoming ordersCreates Bill of LadingsProvides customer service to visitors and callersChecks in and checks out driversEnsures documentation is complete and correct Performs office duties

Quality review of GMP data and Test Procedures

Utilize SOPs in order to audit various aspects of regulated projectsAudit relevant documentation in project notebooks utilized for regulated projects and communicate observations to Project LeadersParticipate in internal and external auditsPrepare audit reports.Assist in preparation of Sponsor or Regulatory Audits Serve as secondary auditor during Vendor AuditsAssist in drafting of SOPs related to Quality SystemReview of documents (SOPs, Test Methods, Project Reports, Validation Protocols and Reports) for compliance with SOPs and cGMP regulationsIssue new and revised SOPs, Test Methods, and ProtocolsProvide compliance support for equipment qualification program through preparation and reviewing of calibration and validation protocols, and Change Control documentationProvide employee training on cGMP and GLP regulationsServe as stability manager back-upReview stability documents and protocolsReview and trend temperature and humidity monitoringReview stability data and reports

Utilize SOPs to audit various aspects of regulated projectsAudit relevant documentation in project notebooks utilized for regulated Participate in internal audits and prepare audit reportsAssist in drafting of SOPs related to Quality SystemReview of documents (SOPs, Test Methods, Project Reports, Validation Protocols and Reports) for compliance with SOPs and cGMP regulationsIssue new and revised SOPs, Test Methods, and Protocols

Review documents for cGMP complianceWrite and review SOPs, test methods, validation protocols, stability studiesPerform laboratory auditsPrepare PowerPoint presentations on data Perform bioanalytical processes for Formulations departmentFormulation design and preparationWrite and initiate stability protocolsPrepare, initiate, and coordinate stability studies

Coordinate auditing of notebooks, final results, and reportsReview documentation for cGMP accuracy Write SOPs and test methodsTrain employees on proper GMP documentation Perform internal audits and laboratory auditsWrite final results, validation, and stability reports

Review documentation for cGMP accuracy Write and review SOPs and test methodsDeveloped a documentation training program to train employees on proper GMP documentationAssisted in the development of an electronic notebook systemPerform internal auditsPerformed validations and IQ/OQSupervised student interns for Analytical Chemistry departmentELISA testing on biological tissue samples

Review for accuracy and cGMP compliance and determined validity of results for final products, raw materials, and research and developmentDelegate assignments to four auditorsWrite stability reportsPerform regular lab audits for cGMP safety and overall complianceReviewed SOPsTrain auditors and chemists on proper documentation

Audit results for accuracy and cGMP complianceTrain auditors and chemists on documentationPerform regular lab audits for cGMP safety and overall complianceReview SOPsPerform final product HPLC testingPerform raw materials bench chemistry work

Hepatitis antibody by RIA and EIANephelometry to quantitate IgG, IgM, IgA, and albumin in AHFAnalyze the potency of Factor VIII and Alpha plasmasAnalyze plasma samples for HIV, HCV, and Hepatitis B antibody by EIAUsed microtiter plate method to determine the isoagglutinin titers (A1 and B) and presence of antibodies to red cell antigen “D” in plasma pools and productsReviewed paperwork to ensure GMP compliancePerformed lab equipment maintenanceReview batch records and paperwork for cGMP compliance and accuracy