Bill Diljak
Manufacturing Technical Writer @Alcami Corporation
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WORK HISTORY
Manufacturing Technical Writer @Alcami Corporation
Research Triangle Park, NC, US
Effectively review batch records and logbooks ensuring quality and regulatory compliance to internal procedures, data integrity, GDP, GMP, and GXP.• Draft SOP for newly commissioned aseptic manufacturing equipment. • Write and update existing Standard Operating Procedures (SOP) for manufacturing. • Identify potential incidents encountered in manufacturing and in documents.• Evaluate risks to assess incidents as comments, events, or non-conformances. • Investigate as Event Reports (ER) or as Root Cause Investigations (RCI).• Write clarifying records as ER events or as RCI deviations.• Devise and propose Corrective And Preventative Actions (CAPA).
EDUCATION
Western Michigan University
Bachelor of Science, Chemistry
Wake Technical Community College
Continuing Education, Biotechnology
ABOUT BILL DILJAK
SCIENTIFIC PROFESSIONALContact me with opportunities w••••••@hotmail.com (91••••••60Global | Product Launches | Regulatory, Compliance, R&D, Quality, & Validation Leader | Inspection-Ready Operations | Regulatory Submissions & Approvals | Accelerate Success | RCA, QRM Assessments, Audits, Inspection Readiness GMP Compliance & Regulations | GxP | GAMP | GLP | GDP | GAP | Laboratory | Instrument Qualification | Optimization | Commission | Validation | IQ/OQ/PQ | Tech Transfer | CMC Documentation | Regulatory Submissions QRM | RCA | CAPA | Data Integrity & Audit Trail Review | FDA / EMA / JP / ROW Regulations | Aseptic Processing | Parenteral Fill-Finish | Cell / Gene Therapy | TrackWise / Veeva Vault Extensive & broad global Science & Industry experiencePharmaceuticalSmall Molecule (Solid, Liquid, Sterile, Aseptic, Parenteral, Inhalation)Biotechnology / BiologicsLarge Molecule (Biotechnology, Cell / Gene Therapy, Vaccines)OtherMedical Device, Nutritional, Personal Care, Cosmetic, Scientific, Start Ups, Bio-Fuel, Contract Development, Manufacturing, TestingDiscoveryR & DQCQAGood Science & Industry Practice (GxP)Good Manufacturing Practice (GMP)Good Documentation Practice (GDP)Good Laboratory Practice (GLP)Good Automation Manufacturing Practice (GAMP)Good Auditing Practice (GAP)Data Integrity, Entry, Review, TrendingLaboratoryCommercialManufacturingReceiveSampleTestDispositionFormulationStabilityPackagingLabelingClinical TrialProductMethod & Process Development, Improvement, Optimization, ValidationWrite, Review, Approve Technical Documents with Regulatory Authority approvals afterNotebookExperimentDataSubmissionChemistry Manufacturing Controls (CMC)SpecificationMethodBatch RecordReportSOPChange ControlProtocolInvestigations (LIR, MIR)CAPAPerformance ReviewDesign, Develop, Establish, Innovate Best Practices. Ensure, Streamline Disciplines, Skills, Teams. Individual & Team ContributorMultidisciplinaryCross-FunctionalGlobalCenter Of ExcellenceBest PracticesTemplatesProcessesBusiness ContinuityAnalyticalInstrumentalProductionCompendiaNon-CompendiaApply Working KnowledgeCode of Federal Regulations (CFR 21)Dietary Supplement Health Education Act (DSHEA)ICHUSPNFFCCBPEPJPROWRoot Cause Analysis (RCA)Quality Risk Management (QRM)DeviationsCorrective & Preventive Actions (CAPA)ReviewInvestigateTroubleshootProblem-solveWriteDeliver & accelerate Analysis, Business, Clinical, Data, Regulatory, Compliance, Research, Quality, CommercialTrainMentorSuperviseManage
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