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Click here or scroll down to respond to this candidateCandidate's Name
Street Address
EMAIL AVAILABLE PHONE NUMBER AVAILABLEPROFESSIONAL EXPERIENCE:New Avon LLC (09/2016 to 11/2018) and Fareva Morton Grove Inc. (12/2018 to 04/2024) Senior Regulatory Compliance SpecialistLed manufacturing teams for over 5 years, overseeing the review, analysis, and validation of processing standards to ensure compliance with FDA regulatory requirements and current Good Manufacturing Practices (cGMP).Reviewed and verified processing standards, batch worksheets and product specificationsManaged MQA activities including internal auditing, manufacturing deviation review, line inspection activities, batch record review and product releaseAssessed and approved product specifications, Processing and Packaging ProceduresInterpreted and implemented regulatory and cGMP requirements, formulating comprehensive compliance strategiesProduced and executed technical support documents including standard operating procedures, change control documentation, and validation protocol assessments.Implemented and oversees Quality systems such as Deviations, Investigations, CAPAs, Change Controls, and Complaints to ensure compliance.Led review and close-out of Non-conformance investigations, uploading a commitment to quality assuranceConducted comprehensive cGMP audits across manufacturing, laboratory, and warehouse facilities, ensuring operational excellenceProvided support during FDA and Canada Health Audits, demonstrating a thorough understanding of compliancePerformed annual product reviews for over-the-counter drugs, ensuring drug integrity and complianceConducted in-depth consumer/customer complaint investigations, identifying root causes and implementing solutionsExecuted computer validation testing and change control testing to drive seamless operationsReviewed manufacturing data and perform the final release of finished products to customers, ensuring quality standards.Performed product label verifications to ensure compliance with FDA regulationsLed re-evaluations of batching/filling, laboratory equipment validation, and drug group process validationsProvided ongoing support to the Quality Manager, specializing in troubleshooting laboratory equipment and test methods, as well as conducting through laboratory investigations Avon Products, Inc. (05/2011 to 09/2016) and New Avon LLC (03/2016 to 09/2016) Senior Quality Control ChemistServed as a local expert in chromatographic techniques (GC/HPLC), spectroscopic technique (UV-Vis, XRF), ChemStation software, and various wet chemistry test methods.Supervised and trained 10+ lab technicians in cGMP, GLP, finished ingredient testing, and raw material testing.Led continuous improvements in process and performance to ensure consistency within laboratory operationsCompleted testing assignments on time in a compliant and efficient manner including analytical testing of raw ingredients, finished product, stability samples, and validation samplesVerified manufacturing documents and released finished goodsInvestigated Out-of-Specification (OOS) test results including performing investigational sample analysis to confirm results and participating in root cause analysis, corrective action formulation and system investigations to ensure compliance to quality requirementsAudited laboratory records to ensure compliance with Laboratory and GMP requirementsReviewed critical documents for completeness, accuracy and compliance with Avon and regulatory requirementsPerformed compendial test method confirmation and Analytical method transfersPerformed periodic reviews of test methods operating procedures and calibration proceduresCoordinated resources to train laboratory associates on instrumentation and analytical test methodsPresented data to external auditors (FDA)Managed equipment systems to ensure GLP compliance including qualification of new equipment and software upgrades, supplier contracts, system suitability, coordinating internal and external calibration, labeling, preventive maintenance, and working with suppliers for new equipment purchases or equipment upgradesManaged stability testing program and equipment (stability chambers)Performed troubleshooting and problem solving for laboratory instruments and analytical test methods Candidate's Name
7511 Kenton, Skokie, IL 60076EMAIL AVAILABLE PHONE NUMBER AVAILABLEOptimized test methods (GC/HPLC), to improve quality, reduce cost and increase productivity. Avon Products, Inc. (09/2000 to 05/2011)Quality Control ChemistTested and released finished ingredient samples, reviewed and verified test results, performed laboratory investigations, and managed chemical/solvent inventoriesTrained Laboratory personnel on new test methods, new instruments, drug order review process, and production release process and demonstrated GLP to associates for improved performanceSupervised HPLC/GC supplier Agilent during upgrade of ChemStation in all HPLC/GC units to enhance robustness of system suitability analysis and reduce processing batch testing downtimeTest Method Development created standard curves for multiple GC, HPLC, UV, and X-Ray test methods, performed test method transfer, executed test method validation with R&D and worked with R&D and equipment supplier Agilent to design peak grouping calculationsResponsible for troubleshooting test methods and instruments including performing preventive maintenance on HPLC, GC, UV, and X-RayAPOTEX Corporation (09/1999 to 09/2000)Research ScientistDesigned and performed pre-formulation and formulation of Parenteral SolutionsCoordinated pre-formulation studiesWrote SOP, protocols and reports, developed/performed cGMP audits and performed cGMP trainingPerformed equipment calibrationCoordinated and performed ANDA batch stability testing and generated formulation documentation necessary for Regulatory Affairs filing of ANDA documentation with the FDA ABBOTT Laboratories (09/1997 to 08/1999)Dissolution ChemistPerformed dissolution testing on tablets and capsules and analyzed samples using HPLC and UVReviewed and verified dissolution data, updated dissolution laboratory procedures and developed dissolution methodsWrote procedures for new equipment, performed laboratory investigations and generated deviations SOLOPAK Pharmaceuticals Inc. (02/1994 to 09/1997)Formulation ScientistCoordinated new product manufacture with Quality and Production DepartmentsWrote master bath records and specifications for products and packagingSupervised pilot batch manufacturingEDUCATION:Masters in Chemistry Roosevelt University, Chicago, IllinoisMasters in Applied Chemistry University of Kerala, India (Major: Oils, Fats and Aromatics)Bachelors in Chemistry University of Kerala, India (Major: Chemistry) Additional Training:Northeastern Illinois University: Method Development and Method Validation in LCChicago Chromatography Discussion Group: Introductory Course in HPLCHarper College for Business: APICS-Basics of Supply Chain Management, Leading Successful Project Teams and Communicating Effectively Working Effectively as a Team Skills: Excellent analytical skills and expertise in laboratory instruments including IR, UV, HPLC, GC, X-Ray, pH meter, Viscometer, Karl Fisher, and Agilent ChemStation Chromatography software, Office 365, and Microsoft Office (Word & Excel) |
