Tina Sammarco Email and Phone Number
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2024 Accomplishments:“This year I successfully completed 25 remote consulting projects this year. It’s been a great yet stressful journey, ensuring companies stay compliant with the applicable regulations.” Business development starts soon! Blessed 😇 With 33+ years plus of enriched experience in the chemical, pharmaceutical, and medical device industries, Tina Sammarco is a stalwart of expertise and unwavering dedication. Her professional journey began with an intensive apprenticeship in organic chemistry through the renowned Eastman Chemical Company's laboratory program, laying a solid foundation for a storied career.For a decade, Tina Sammarco refined her acumen in the realm of Raw Materials, mastering the complex facets of sourcing and quality control that are vital for production excellence. Her deep knowledge then paved the way for a pivotal seven-year tenure as a chemist for generic drugs, where she played a leading role in enhancing drug efficacy and safety, driving advancements in generic drug formulations.Her expertise in the field was further cemented with four years dedicated to overseeing US medical device facility builds and relocation projects, showcasing her strategic foresight and comprehensive understanding of operational logistics. This invaluable experience set the stage for her remarkable nine-year engagement with international projects. Tina Sammarco was instrumental in overcoming Consent Decrees and resolving Import Bans, contributing to the successful establishment of multiple pharmaceutical facilities around the world.Working alongside legal advisors,Tina Sammarco has expertly bridged the gap between scientific expertise and regulatory compliance, ensuring that projects not only meet but exceed the stringent standards of the industry. Her exceptional skill in articulating complex technical concepts to legal teams has been essential in risk mitigation and the seamless execution of projects.Tina Sammarco's biography is a testament to a professional life dedicated to the pursuit of excellence, underscored by a fervent passion for the advancement of the chemical and pharmaceutical sectors. She remains an invaluable source of knowledge and an asset to any initiative within the chemical and pharmaceutical landscapes.
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T Carter Consultant, IncFlorida, United States
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Managing Partner - Business DevelopmentStrategy Intelligence Recruiting 2023 - Present
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Principal ConsultantCompliance At T Carter Consulting, Inc. Jan 2018 - PresentLaboratory, Quality Systems, and Manufacturing Compliance Auditor for the FDA/MHRA industries. Project Construcition and Validation Manager Facility Builds.
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Small Business OwnerThe Facial Bars Of Florida Oct 2019 - Present
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Senior AuditorThe Auditing Group Mar 2015 - PresentMedford, UsInternal Auditing India
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Laser/ Intense Pulse Light, ElectrolysisT Carter Consultant, Inc. Oct 2019 - Present
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Principal ConsultantSmart Pharmaceutical Consulting (Spc) Apr 2019 - PresentWest Chester, Pennsylvania, UsQuality Systems For Phase 3 TTI -
Principle Consultant ParexelPfizer Pharmaceutical India Pvt. Ltd. Jun 2018 - PresentGlobal SME -
Lean Lab Designer ConsultantSmart Pharmecutical Consulting Feb 2015 - PresentFacility Laboratory Designer and Lean Lab Management
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Qa Representative Biologic DeviceGlobal Biopharma Solutions Nov 2017 - PresentVirtual Biologic Device( Combination Product ) Quality Management System IND Start Up
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Managing PartnerT Carter Consulting, Inc Apr 2017 - PresentTaking a break from the Corporate America and developing a new business and product.
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Senior ConsultantFda Remediation Services, Inc. Feb 2015 - PresentDomestic and International Remediation Services for Data Integrity, Compliance Issues, 483's and Warning Letters, Consent Decrees and potential Import Band Alerts. , Former FDA Agents, Former FDA Lawyers in addressing regulatory findings.
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Lean Lab DesignSmart Consulting Group, Llc Jun 2016 - PresentWest Chester, Pennsylvania, UsLab redesign and steam line testing processes. -
Senior ConsultantSmart Consulting Group, Llc Dec 2014 - PresentWest Chester, Pennsylvania, UsConfidential Information at this time.
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Engineering Project SpecialistConfidential Sep 2015 - PresentFacility Build and Validation Consultant for Research and Development Company that's going ISO13485- "Quality"
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Medical Device And Pharmaceutical ConsultantIndependent Consultant Apr 2011 - PresentClass III Medical Devices and Solid Dose Pharmaceuticals; commissioning of facilities, utilities validation, cleanroom certification, equipment set up and validate manufacturing processes in an ISO class environment.
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Project ManagmentFda Remediations Services, Inc Oct 2009 - Present
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Project ManagerFda Remediation Services, Inc Jan 2009 - Present
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Company OwnerT Carter Consultant, Inc Oct 2019 - Mar 2020
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Qa Consultant 503A CompoundingUs Compounding Jan 2018 - Jan 2018503A Sterile Aseptic Facility Relocation Project Design Review. Preformed Verification Activities from prior consulting audits and compliance review to the new 503A and 503B Compounding Regulations.
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PresidentConsulting 2007 - 2017
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LeadParexel 2013 - 2016Durham, North Carolina, Us -
Ic Consultant, Auditor/ RemediationParexel Jan 2013 - Mar 2014Durham, North Carolina, UsPerformed cGMP baseline audit inspections, as part of the Consent Decree with a confidential Pharmaceutical client in US and Asia.
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Pharmaceutical ConsultantCurrently Seeking Jan 2009 - Apr 2015Solid Oral Dosage, Sterile Aseptic and Medical DeviceHealth Authorities Remediation AssistanceWarning LettersConsent Decree Auditing Program Management Quality Systems Import Ban Solutions
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Project Remediation ConsultantSmart Consulting Group Mar 2012 - Sep 2012Project managed a team of 12 consultants on lifting a warning letter on a controlled substances/ liquid mfg site within six months. By utilizing the 21 Quality Element Approach developed by Smart Consulting Group and Validating Controlled/Liquid Product to the new FDA Guidance for Validation lead this project to success. -
Project Manager QuintilesInternational Company India May 2009 - Sep 2009My services to assist a third party consultant company to Quintiles were project manage an audit team of 10 for customer complaints,bio studies,and laboratory data; audit team consisted of 4 former FDA consultants,and team of experience subject matter experts. Assisted the VP of the project on presentations to the executive team, assist team in response letter to the FDA and manage meeting audit task time lines,and project logistics.
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Project Manager AbAdvanced Bionics 2008 - 2009Santa Clarita, Ca, UsAssisted management with the relocation expansion project for a class 3 medical device for utilities and process validation. -
Validation ConsultantPld Developments 2008 - 2009Assisted on a Due Diligence audit on quality systems on a liquid company
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Quality Consultant/ Project ManagerBoston Scientific Apr 2007 - Nov 2008Marlborough, Ma, UsValidation Utilities/Process and Quality Consultant Medical DeviceAssisted on the Relocation of the Facilities 54 Million Dollar Project -
Validation/Quality ConsultantBioness May 2008 - Sep 2008REVELANT WORK HISTORY:2008 – Sept 2008 Bioness Inc. Facilities Consultant for a Medical Device Company, Utilities ValidationValencia, CA
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Project Manager Validation And Facility BuildsPharmatech Associates 2007 - 2008Hayward, California, UsDirected and managed project teams with client and 10+ validation and quality consultants for a relocation expansion project -
Senior Investigator, Qc Laboratory Supervisor, ChemiistWatson Jul 2000 - Jul 2007•Lead investigator for complex investigations for the manufacturing areas investigation experierence include but not limited to: Glatt, Tablet Coaters, Packaging,Granulation stages.•Perform complex and non-complex investigations for non-conformance deviations, laboratory out of specification results, and customer complaints.•Track deviations through completion and approval of the report.•Present investigation findings to the management review board (MRB).•Identify root cause(s), provide and recommend corrective and preventive actions for deviations of procedures.•Update, revise and maintain databases to meet Quality Assurance reporting requirements. •Review validation processes, protocols, analytical testing results, stability data, equipment, and calibration records to ensure compliance with established procedures, perform customer complaint investigations according to standard operating procedures and FDA regulations.
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Senior Capa Investigator , ChemistAndrx 2000 - 2007UsFPP- FLORIDA PHARMACEUTICAL PRODUCTSLooking for manufacturing facilities to manufacture generic drugs for FPP.
Tina Sammarco Skills
Frequently Asked Questions about Tina Sammarco
What company does Tina Sammarco work for?
Tina Sammarco works for T Carter Consultant, Inc
What is Tina Sammarco's role at the current company?
Tina Sammarco's current role is Business Development and Client Services.
What is Tina Sammarco's email address?
Tina Sammarco's email address is ti****@****ail.com
What skills is Tina Sammarco known for?
Tina Sammarco has skills like Validation, Fda, Quality System, Gmp, V&v, Sop, Capa, Regulatory Affairs, Cleaning Validation, Quality Auditing, Technology Transfer, Quality Assurance.
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