Lori Eccleston Email & Phone Number

Columbia, Md, Us

Columbia, Md, Us

• Develop and implement Clinical Quality Policy, Quality Manual, Standard Operation Procedures (SOPs), and quality records in compliance with ISO 9001:2015, ISO 13485:2016 and/or 21 CFR part 820.• Serve as a subject matter expert during audits, inspections and assessments by regulatory agencies and customer audits. • Perform and document Internal Quality Assurance Audits. Perform gap assessments against new and revised Quality Directives and ISO requirements.• Prepare and submit reports, such as FDA Annual X-Ray and Laser Reports, NEWMOA IMERC, EPA Mercury, EPA TSCA Import/Export Certificates, U.S. NRC ECD, and Canada Nuclear Regulator reports within the required timelines. • Manage, develop, and/or revision of Quality Management System procedures and processes.• Manage document control and ensure timely release of Quality records. • Responsible for interfacing with other departments to ensure applicable regulatory requirements are met. • Provide company-wide training on regulatory requirements, such as GLP, GMP, GCP, and Iso requirements.• Support Medical Device reporting and post-market compliance for clinical medical devices. • Coordinate with Japan and other Manufacturing subsidiaries to ensure supplied product meets published standards (ISO, CSA, CE Mark and others)

Columbia, Md, Us

• Develop and implement Clinical Quality Policy, Quality Manual, Standard Operation Procedures (SOPs), and quality records in compliance with ISO 9001:2015, ISO 13485:2016 and/or 21 CFR part 820.• Serve as a subject matter expert during audits, inspections and assessments by regulatory agencies and customer audits. • Perform and document Internal Quality Assurance Audits. Perform gap assessments against new and revised Quality Directives and ISO requirements.• Prepare and submit reports, such as FDA Annual X-Ray and Laser Reports, NEWMOA IMERC, EPA Mercury, EPA TSCA Import/Export Certificates, U.S. NRC ECD, and Canada Nuclear Regulator reports within the required timelines. • Manage, develop, and/or revision of Quality Management System procedures and processes.• Manage document control and ensure timely release of Quality records. • Responsible for interfacing with other departments to ensure applicable regulatory requirements are met. • Provide company-wide training on regulatory requirements, such as GLP, GMP, GCP, and Iso requirements.• Support Medical Device reporting and post-market compliance for clinical medical devices. • Coordinate with Japan and other Manufacturing subsidiaries to ensure supplied product meets published standards (ISO, CSA, CE Mark and others).

Columbia, Md, Us

• Facilitate on site audits and represent Management on behalf of SSI. • Serve as a subject matter expert during audits, inspections and assessments by regulatory agencies and customer audits. • Perform and document Internal Quality Assurance Audits. Perform gap assessments against new and revised Quality Directives and ISO requirements • Prepare and submit FDA Annual X-Ray and Laser Reports within the required timelines. • Ensure compliance with EPA TSCA import regulations. • Management quality management system for clinical medical devices and document control system• Manage, develop, and/or revision of Quality System procedures and processes. Maintain and organize files for quality and compliance records. • Coordinate with other departments to define/develop specific compliance training to ensure company-wide knowledge of the quality system and meeting compliance requirements. • Coordinate with Japan and other Manufacturing subsidiaries to ensure supplied product meets published standards (ISO, CSA, CE Mark and others). • Coordinate with other departments to respond to customer and supplier questionnaire in a timely fashion

Owings Mills, Maryland, Us

• Quality & Documentation Specialist contracted at Shimadzu Scientific Instruments• Develop and implement Clinical Quality Policy, Quality Manual, Standard Operation Procedures (SOPs), and quality records in compliance with ISO 9001:2015, ISO 13485:2016 and/or 21 CFR part 820.• Serve as a subject matter expert during audits, inspections and assessments by regulatory agencies and customer audits. • Perform and document Internal Quality Assurance Audits. Perform gap assessments against new and revised Quality Directives and ISO requirements.• Prepare and submit reports, such as FDA Annual X-Ray and Laser Reports, NEWMOA IMERC, EPA Mercury, EPA TSCA Import/Export Certificates, U.S. NRC ECD, and Canada Nuclear Regulator reports within the required timelines. • Manage, develop, and/or revision of Quality Management System procedures and processes.• Manage document control and ensure timely release of Quality records. • Responsible for interfacing with other departments to ensure applicable regulatory requirements are met. • Provide company-wide training on regulatory requirements, such as GLP, GMP, GCP, and Iso requirements.• Support Medical Device reporting and post-market compliance for clinical medical devices. • Coordinate with Japan and other Manufacturing subsidiaries to ensure supplied product meets published standards (ISO, CSA, CE Mark and others).

Gaithersburg, Maryland, Us

• Work with Chief, NCD, Study Directors, principal investigators, and other key staff to perform QC reviews of documents and records associated with nonclinical studies under FDA GLP requirements.• Perform QC review of laboratory study files and records to assure that calculations, content, reference, etc. are technically correct and complete for submission for QA audit.• Perform QC review of GLP study final reports and other high visibility final reports to assure that submission for QA audit.• Coordinate and manage troubleshooting, unexpected incident investigations, and corrective action/preventive action (CAPA) activities • Coordinate activities with Study Directors and study personnel. • Coordinate with QA staff on scheduling and quality standards for submissions for QA audit• Ensure compliance with FDA regulations, e.g. 21CFR314, where the goal is inclusion in FDA animal rule submission in review of records and documents.• Apply scientific knowledge and regulatory expertise in executing assignments • Remain abreast of current FDA regulatory requirements, guidance, and current thinking to enhance the expertise and awareness of staff. With input from Chief, the contractor shall conduct internal training to ensure staff and study team personnel are appropriately trained for their respective job functions. • Provide advice on, review, and revise SOPs, testing plans, and protocols related to laboratory testing analytical methodology and general laboratory activities. • Reviews and recommends improvements to standard operating procedures (SOPs) and instructions for all quality activities to include the quality assurance plan, systems monitoring, internal auditing, and improvement and corrective plans (CAPAs).• Reviewing training records to assure personnel are trained in GLP• Ensures records and systems are in compliance with standards, regulations, and procedures by conducting reviews.• Completed HIPPA training

Gaithersburg, Maryland, Us

• Support a variety of laboratory-based activities associated with FDA regulatory compliance, analytical method optimization & validation.• Develop standard operating procedures (SOPs) study-specific procedures (SSP), etc. to ensure compliance with Good Laboratory Practices (GLP) regulation.• Review protocols, study plans, and associated documentation to support research and development projects under GLP for products regulated by the Food and Drug Administration.• Organize and tabulate laboratory records and resulting data to ensure complete study files.• Assist investigators to ensure that PI written reports are in compliance with appropriate standards, e.g., 21 CFR regulations.• Assist principal investigators in developing documentation packages from laboratory studies that can support investigational and new drug applications (IND/NDA).• Perform laboratory quality management activities for supported customers to the required quality standard, e.g., GLP. Supports analytical method validation studies to support use in FDA-regulated studies.• Support medical or advanced animal research, including Animal Rule Studies, by assisting GLP compliant studies of investigational specimens from these studies, as an optional requirement.• Support SIP Program by assisting GLP compliant studies for potency testing of clinical research materials.• Support product release testing (potency, identity, stability) for cGMP manufactured materials.• Ensure that integrity of the data and the quality of all studies meets acceptable quality levels, to include tracking and storage of investigational materials.• Assist with study scheduling including procurement of key supplies and materials• Assist with storage, retrieval and inventory of test articles and other study-related critical reagents• Acted as the backup GLP archivists • Order supplies through DLMSS and GFEBs

Gaithersburg, Maryland, Us

Biodefense Regulated Laboratory Analyst at USAMRIID • Develop and review standard operating procedures (SOPs) study-specific procedures (SSP), study protocols, study plans, PI written reports, quality records, and study data files etc. to ensure compliance with Good Laboratory Practices (GLP) and 21 CFR 11, 58, and 314 compliance.• Support product release testing (potency, identity, stability) for cGMP manufactured materials, SIP Program by assisting GLP compliant studies for potency testing of clinical research materials, and investigational and new drug applications (IND/NDA).• Provide advice on, review, and revise Standard Operating Procedures (SOPs), testing plans, and protocols related to laboratory testing analytical methodology and laboratory activities. • Acted as the backup GLP archivists.• Coordinate and manage troubleshooting, unexpected incident investigations, and corrective action/preventive action (CAPA) activities.• Conduct training on GLP and FDA regulations, e.g. 21CFR 11, 58 & 314. • Responsible for interfacing with other departments to ensure applicable regulatory requirements are met.

Gaithersburg, Maryland, Us

• Conducts research in a BSL-3 high containment laboratory as part of a team in support of US Army’s directive to develop vaccine and exposure theraputics to multiple alphaviruses. • Responsible for the management, safeguard, and storage of Biological Select Agent/Toxins (BSAT) in accordance with DOD, DA, Army, Federal, State and USAMRIID regulations•Responsible for the management of select agents and toxins within the Agent Inventory Magagement System database •Ensure the acquisition, storage, use, transfer, and destruction of BSAT within the BSL3 bio-containment laboratory •Involved in the inventory audits of the BSAT •Manage stocks of select agent plasmids, synthetic genomic materials, and other infectious agents •Work on drug screens againist different alphaviruses Performs various viral immunological assays in support of efficacy studies, VLP and VRP vaccines studies, alphavirus pathogenesis studies, and screening various vaccine candiates •Evaluates therapeutic antibody based molecules in a range of cellular assays•Assist in the development of murine and NHP models •Performs ELISAs, polymerase chain reactions (PCR), DNA sequencing, plaque assays, plaque neutralization assays, cell based assays, colormetric assays, and gel electrophoresis •Performs RNA, DNA, and protein extractions•Expertise in the maintenance and propagation of multiple cell and tissue culture lines•Grows, isolates and purifies viral stocks •Assists in the preparation of animal tissue samples for hischemical studies•Responsible for the management, safeguard, and storage of BSAT, animal tissue samples, and working stock samples •Actively maintains up-to-date protocols accessable and utilized by entire research team to include multiple laboratory notebook of all studies performed•Serves as mentor to individuals new to BSL-3 containment work, to include training on all above stated assays, saftey procedures, and standard operating procedure of the research team

Gaithersburg, Maryland, Us

Biological Science Laboratory Technician at USAMRIID• Develop and review standard operating procedures (SOPs) study-specific procedures (SSP), study protocols, study plans, PI written reports, and study data files etc. to ensure compliance with Good Laboratory Practices (GLP) and 21 CFR 11, 58, and 314 compliance.• Conducted studies under well documented and GLP and/or GCP conditions.• Involved with the characterization of Alphavirus model development stocks and the testing of antiviral therapies for efficacy in Alphavirus mouse models of subcutaneous and aerosol infection. • Support Virus-Replicon Particle (VRP) and Virus-like Particles (VLP) Vaccine Development in Non-human Primate Animal Models, alphavirus pathogenesis studies, and therapeutics studies• Responsible for the management of Biological Select Agent/Toxins (BSAT) within the Agent Inventory Magagement System (AIMs) database • Performs ELISAs, polymerase chain reactions (PCR), DNA sequencing, plaque assays, plaque neutralization assays, cell based assays, colormetric assays, gel electrophoresis, viral stock isolation, viral stock purification, RNA, DNA, and protein extractions• Expertise in the maintenance and propagation of multiple cell and tissue culture lines• Assists in the preparation of animal tissue samples for hischemical studies• Worked with our Quality Assurance department to improve SOPs and assay development• Served as mentor to BSL-3 containment work team members• Responsible for interfacing with other departments to ensure applicable regulatory requirements are met.

Veterinary Medicine Quality Control Support at USAMRIID at Fort Detrick, MD• Develop and implement Standard Operation Procedures (SOPs), and quality records in compliance with GLP regulations and FDA regulations, e.g. 21CFR 11, 58 & 314.• Work with Chief, NCD, Study Directors, principal investigators, and other key staff to perform QC reviews of documents and records associated with nonclinical studies, to include those conducted under FDA GLP requirements.• Perform QC review of laboratory study files, laboratory records, and GLP study final reports to assure that calculations, content, reference, etc. are technically correct and complete for submission for QA audit.• Perform and document Internal Quality Assurance Audits.• Coordinate and manage troubleshooting, unexpected incident investigations, and corrective action/preventive action (CAPA) activities related to NCD-supported studies and facilities. • Ensure compliance with FDA regulations, e.g. 21CFR 11, 58 & 314. • Provide advice on, review, and revise Standard Operating Procedures (SOPs), testing plans, and protocols related to laboratory testing analytical methodology and laboratory activities. • Conduct training on GLP and FDA regulations, e.g. 21CFR 11, 58 & 314. • Responsible for interfacing with other departments to ensure applicable regulatory requirements are met. • Completed HIPPA training

• Conducted studies under well documented and GLP and/or GCP conditions.• Involved in the study of the NicVAX vaccine and vaccines to treat respiratory-related viral infections• Assisted in the preparation of technical reports and protocol summaries• Reviewed experiment Quality Control Final Reports• Assisted the Quality Control Department in performing ELISA Assays during murine studies • Maintain lab cleanliness, prepare various media, stock supplies, and other reagents for use in the laboratory• Assisted in fermentation procedures for protein development • Undertook completion of the Hazardous Material Use Certificate documentation for Montgomery County, Maryland.

•Assisted in the preparation of technical reports and protocol summaries•Reviewed experiment Quality Control Final Reports•Assisted the Quality Control Department in performing ELISA Assays during murine studies for the NicVax Vaccine•Prepared SOPs and reviewed laboratory protocols•Maintain lab cleanliness, prepare various media, stock supplies, and other reagents for use in the laboratory•Assisted the Research and Development Department in fermentation procedures for protein development •Performed laboratory service functions, to include cleaning and sterilizing glassware•Undertook completion of the Hazardous Material Use Certificate documentation for Montgomery County, Maryland.

Master'S Degree, Biology/Biological Sciences, General

Bachelor'S Degree, Biology/Biological Sciences, General