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As a seasoned professional with extensive experience in Quality Assurance (QA), Validation, and Manufacturing Operations within the pharmaceutical industry, I bring a unique blend of technical expertise and leadership skills to every project. With a Bachelor of Science in Biology and Chemistry from the University of Hartford, I have honed my abilities in Six Sigma/LEAN Training, Program/Project Management, and Process/Procedure Development, ensuring high-quality outcomes and regulatory compliance.Throughout my career, I have been instrumental in Product Release/Launch, Deviation Investigation/Support, and Product Disposition across US/EU markets. My proficiency extends to Monitoring/Inspections/Auditing, Filter Validation and Assessment, Quality Risk Assessment Practices, and Quality Testing, including In-Process, Drug Substance, Drug Product, Stability, and Microbiology Samples. My technical acumen is further demonstrated by my expertise in Deviation Management, CAPA Management, and the use of advanced systems like LIMS (GLIMS), MODA System, TrackWise, and SAP.In my roles at leading organizations such as Curia Global, Catalent, PCI Pharma Services, Moderna, and Novavax, I have led cross-functional teams to develop and implement best practices, reduce production downtime, and enhance quality management systems. My contributions have consistently resulted in improved operational efficiencies and compliance with industry standards.One of my key strengths is my ability to provide coaching and guidance to manufacturing and quality groups, fostering a culture of continuous improvement. I have successfully led initiatives in system innovation, technology/product transfer, raw material testing, and safety/regulatory compliance. My approach to problem-solving is rooted in robust methodologies like the 5 Whys/Fishbone and Root Cause analysis techniques, ensuring effective resolution and prevention of issues.I am passionate about driving excellence in the pharmaceutical industry and am eager to bring my skills and experience to new challenges. Let's connect to discuss how I can contribute to your organization's success and help achieve your quality and operational goals.
Pharmaceutical
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Global Cmo Senior Sme Qa Operations, Manufacturing, And ValidationPharmaceuticalUnited States
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Global Cmo Senior Sme Qa Operations, Manufacturing, And ValidationPharmaceutical Mar 2023 - Present
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Cmo Senior Sme Quality AssuranceModerna Dec 2022 - Mar 2023Cambridge, Massachusetts, Us -
Cmo Senior Quality Assurance SpecialistNovavax Oct 2021 - Dec 2022Gaithersburg, Maryland, Us -
Senior Quality Assurance SpecialistModerna Dec 2020 - Oct 2021Cambridge, Massachusetts, Us
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Senior Validation EngineerKse Scientific Oct 2020 - Dec 2020
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Senior Quality Control (Microbiology Environmental Monitoring) SpecialistLonza Sep 2019 - Sep 2020Basel, Ch -
Senior Quality Control Microbiology/Process Review Improvement Specialist (Quality Control System)B. Braun Medical Inc. (Us) Jun 2019 - Aug 2019Bethlehem, Pa, Us -
Lead Process Review And Improvement (Quality Control System And Manufacturing Controls)Dr Reddy Laboratories Ltd Feb 2019 - Apr 2019
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Quality Assurance/Quality Control Batch Record DocumentationAldevron Nov 2018 - Feb 2019Fargo, North Dakota, Us -
Aseptic Manufacturing Quality Specialist (Qa Validation Manufacturing)Akorn, Inc Jun 2018 - Oct 2018Lake Forest, Il, UsPrepared and executed protocols and technical studies related to the development and excavation of Media Fill Simulation for aseptic manufacturing. -
Quality Control Laboratory Operations SpecialistLonza May 2017 - Jun 2018Basel, ChResponsible for defining and executing requirements of Environmental Monitoring Program (EM) and Cleaning Validation of tanks and classified manufacturing areas.
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Supervisor, Environmental Monitoring/Lead Environmental Monitoring ScientistXellia Pharmaceuticals Feb 2015 - Jan 2017Copenhagen, Dk•Supervises daily activities of scientists and technicians. Assures that job activity deadlines are met on a timely basis. Ensures daily quality concerns and questions are being adequately addressed by department personnel. Assure proper and timely testing. •Assures execution of monitoring and testing programs to assess the microbiology quality parameters of in-process, environmental systems and effectiveness of production processes. •Establishes goals for the timely release of product and performance of projects. Monitors performance of the group against the goals to identify and implement needed corrective action. •Ensures that product or an environmental system not meeting specifications and limits is promptly investigated. Identifies possible source and corrective action needed and evaluates the impact upon the lot.•Identifies significant adverse quality trends by preparing and analyzing summary reports. Addresses quality control test results, microbial profiles of environmental systems.•Oversees area deviation investigations, CAPAs, and change controls for technical and compliance of regulatory requirements.•Assist in risk mitigation plans, validation protocols, and technical review of CAPAs and change controls. Ensures adequate evaluation of new product processes. Supervises validation activities for responsible area. -
Quality Assurance SpecialistNovartis May 2014 - Feb 2015Basel, Baselstadt, Ch•Ensures that all aspects of United States Flu Cell Culture (US FCC) Vaccines operations comply with the requirements of the Novartis V&D Quality manual and meets all relevant cGMP regulatory requirements.•Management of all quality assurance activities and procedures during 3rd shift.•Supports the development of quality systems for QA oversight of manufacturing processes, in-process sampling and control, quality systems and QA compliance.•Supports the development and implementation of standard operating procedures (SOPs) and supplemental documents governing management and usage of each quality system of responsibility. •Provides training for the site on each quality system including system roll out, use and maintenance. •Perform routine quality audits of both Manufacturing and QC laboratory environments, equipment, and procedures.•Acquires and maintains knowledge of current local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters are provided to the site, including Deviation Reports and CAPAs.•Batch record review concurrent to completion of manufacturing operations in real time and post production batch record review of supporting documents. -
Quality EngineerHospira Aug 2013 - May 2014Lake Forest, Il, UsConducting and writing formal investigation reports, exception reports, and CA/PA’s for the Biological Quality Department to ensure product release for the world's largest producer of generic inject-able pharmaceuticals, integrated infusion therapy and medication management systems. • Conducting and writing of formal investigations for plant quality issues, including production, quality systems, validation studies, and utilizes (city-water treatment, water purification, pharmaceutical air, and instrument air)• Perform impact assessments and investigate, in varying depths, with the identified risk to product condition and potential patient impact. • Provide quality consulting to different investigations and assist in root cause determination. • Facilitate identification of appropriate Corrective Actions and Preventive Actions (CA/PA) to support plant and corporate activities related to the different systems within but not limited to the Quality Department. • Track and trend Corrective and Preventive Actions for plant quality issues to assure timely closure and effectiveness.• Review and evaluate sensitive, confidential information and develop recommendations for use by the Biological Quality Department. -
Sls Microbiology Validation Associate Scientist IiPall Corporation Aug 2011 - Aug 2013Port Washington, New York, UsDirected all aspects of quality control for laboratory and testing operations to ensure cGMP and regulatory compliance of all products released for a global Fortune 1000 materials science and engineering company serving clients in health care, biotechnology, pharmaceutical, semiconductor, municipal water, aerospace and industrial manufacturing environments.• Developed laboratory and field test protocols and procedures and managed customer specific validation projects; collaborated with senior management in the creation of standardized processes and procedures. • Executed protocols and finalized reports; analyzed data and prepared documentation for product release.• Performed extensive filter validation testing including Bacterial Retention, Viability, Compatibility and Filterability testing; ensured and enforced product adherence to strict quality standards for biopharmaceutical clients.• Conducted in-depth laboratory investigations and issued corrective action reports to maintain quality control. -
Quality Control Microbiology Analyst IiGrifols Jul 2006 - Aug 2011Sant Cugat Del Vallès, Barcelona, EsProvided quality leadership for all aspects of laboratory operations for a leading Spanish-based multinational pharmaceutical and chemical company.• Identified and implemented process improvements; assisted with Standard Operating Procedure (SOP) revisions and the development of corrective actions.• Conducted quarterly safety audits on laboratory equipment and all materials within the laboratory environment.• Collaborated with the Validation and Manufacturing Departments to develop efficient and timely sampling procedures for in-process samples.• Managed all aspects of environmental monitoring, including total particulates, viable airborne particulates and viable surface particulates in Class 10,000 (ISO 7) and Class 100,000 (ISO 8) rooms.• Performed nutrient media suitability studies on commercial grown media for laboratory use.• Ensured and studied disinfectant efficacy on different surfaces within the manufacturing facility including process, bulk and holding tanks.• Conducted bioburden analysis and endotoxin on process samples.• Integral member of the Talecris Melville Safety Committee.
Terry Williams Skills
Terry Williams Education Details
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University Of HartfordBiology And Chemistry
Frequently Asked Questions about Terry Williams
What company does Terry Williams work for?
Terry Williams works for Pharmaceutical
What is Terry Williams's role at the current company?
Terry Williams's current role is Global CMO Senior SME QA Operations, Manufacturing, and Validation.
What is Terry Williams's email address?
Terry Williams's email address is te****@****ail.com
What schools did Terry Williams attend?
Terry Williams attended University Of Hartford.
What skills is Terry Williams known for?
Terry Williams has skills like Validation, Gmp, Biotechnology, Pharmaceutical Industry, Quality Control, Microbiology, Change Control, Lifesciences, Sop, Biopharmaceuticals, Quality Assurance, Laboratory.
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