Gregory N. Email & Phone Number

• Principal auditing consultant for audits of GMP/GLP/GCP facilities for regulatory compliance.• cGMP/GXP manufacturing Project/Program Management Services. Assisting in the demonstration of new laboratory systems.• QA documentation review and revision services.• Provide expert guidance on project management methodologies, implementing best practices such as Agile and SCRUM to improve project delivery times and outcomes.• Develop comprehensive quality management systems for clients, enhancing their operational efficiency and compliance with FDA and ICH guidelines. Communicating project requirements, goals, and timelines effectively.• Consult, Implement and develop business operations.

Santa Barbara, Ca, Us

• Managed laboratory operations projects, including new instruments, new software, and process improvements.• Worked closely with Global Quality Control (GQC) and Analytical Development and Operations (ADO personnel to determine laboratory needs and user requirements.• Assisted in the demonstration of new laboratory systems.• Worked with Facilities Operations in site planning and preparation for instrument installations.• Reviewed documents pertaining to system implementations, including protocols, procedures, work instructions, and guidelines.• Collaborated closely with procurement and vendors to perform detailed quote reviews with relevant team members to ensure correct purchasing of assets, accessories and services. • Communicating project requirements, goals, and timelines effectively.• Currently driving continuous improvement initiatives by identifying and eliminated waste in equipment usage and storage practices in a cooperative cross-functional manner.• Presented project summaries and status updates to large groups through PowerPoint and verbal communication.• Participated in meetings with vendors and the Vendor Service Team as needed.• Applied knowledge of current Good Manufacturing Practices (cGMPs) concepts.• Successfully implemented and executed Agile, SCRUM and/or Hybrid management methods as needed.

New Jersey, Nj, Us

• Leveraged extensive knowledge of consumer electronics and analytical testing methods, including HPLC, ICPMS, LC/MS, and GS/MS, to guide biocompatibility reviews and assessments throughout product development stages.• Collaborated with cross functional teams and suppliers to select and validate biocompatible materials, ensuring alignment with product development specifications and regulatory standards.• Spearheaded the coordination and management of sample testing, tracking analytical results, and assessing biocompatibility to establish and refine product development processes.• Developed and implemented efficient workflows, SOPs, and tracking systems to enhance communication and data integration across functional teams and with external partners.• Communicated effectively with peers, subject matter experts, and leadership, presenting biocompatibility goals and findings to facilitate informed decision making and strategic planning.• Prioritized and managed multiple program timelines within a dynamic, fast paced environment, consistently meeting critical project milestones and deliverables.

Basel, Ch

• Testing using the following assays: GP HPLC, HPGC, FTIR, A280, Ramen Spec, O2, and Osmolality.• Perform urgent and critical testing under short notice to support manufacturing.• Logistical handling of raw materials, including shipping and identification testing.• Reviewing of analytical results and completion of release functions in LIMS.• Performing deviation investigations with lab investigation reports.• Creating, revising, and reviewing quality GMP documents, i.e., local SOPs and assay worksheets.• Supporting and leading projects – such as method transfers, new instruments, method qualifications.• leading continuous improvement projects in the Stability Laboratory such as 5S, Kaizen, Just-do-it's, and VIP.• Performing equipment maintenance and calibrations as required.• Supporting execution of validations for lab equipment, lab methods, or facility projects.• Ensuring personal training requirements are met and that training records are current.

Herndon, Virginia, Us

• Conducting analytical and functional testing of finished kits and filled bottle reagents/calibrators as part of QC release and surveillance testing.• Performing testing using chemistry clinical analyzers and documenting test results for weekly product release.• Carry out testing according to established stability time points and ensuring timelines are met as per protocol.• Documenting test results, completing batch report, handling problems with proper documentation under cGMP and GDP environments.• Performing revisions and updates to QCIs, SOPs and worksheets as necessary and initiating document changes.• Interpreting and summarizing test data, maintaining lot history and evaluating data for trends and discrepancies.• Receiving and logging in samples into inventory system and pulling retains upon requests.• Programming clinical analyzers the correct parameters and concentrations as per protocol and SOP.• Carry out testing according to established stability time points and ensuring timelines are met as per protocol.• Documenting test results, completing batch report, handling problems with proper documentation under cGMP and GDP environments.• Performing revisions and updates to QCIs, SOPs and worksheets as necessary and initiating document changes.• Interpreting and summarizing test data, maintaining lot history and evaluating data for trends and discrepancies.• Receiving and logging in samples into inventory system and pulling retains upon requests.• Programming clinical analyzers the correct parameters and concentrations as per protocol and SOP

Ukiah, Ca, Us

• Provided analytical and operational support under the guidance of the Laboratory Director, Quality Control Director, and Bay Area Sales & Operations Management.• Current production work includes regulatory sample analysis via certified methodology, including Algal analyses, BOD, coliform analyses (Colilert, Colisure and MPN methods), General Physical analyses (color, odor & turbidity) and other methods.• Carried out emergency analyses based on client request.• Logged and received samples while handling document controls as per TNI/NELAC, GDP & GLP policies, regulations, and practices.• Managed LIMS for data entry, batching, work orders and inventory.• Monitored controlled temperature environments through careful calibration, operation, and maintenance of laboratory equipment.

Luxembourg, Luxembourg, Lu

• Arranged and managed stability pharmaceutical drug studies in a GMP environment.• Monitored, logged, and reconciled stability drugs using ValGenesis, openLab, Labvantage REES, & lifeDoc.• Edited and authored SOPs and Protocols as needed.• Analyzed samples for Visible Particulates as per protocol followed up with LIMS data entry.• Performed aliquoting of drug substances and drug products.• Completed yearly inventory reconciliation/disposition for stability studies.• Initiated deviation reports for chamber excursions, inventory discrepancies.• Managed database with LIMS (laboratory management software) Entering protocol information into studies program.• Created and distributed weekly pending reports to labs for sample delivery notification.• Filed various stability study records and maintain constant audit preparedness.• Reviewed stability data verification for summary documents.• Initiated work orders and LIMS change requests.• Captured quantitative information on batches of raw data from our QC department.

• Composed analytical reports, electronic data files and state EDT transfers, preparing monthly reports utilizing previous knowledge of water chemistry in a GLP environment.• Preparing Chain of Custody reports, bottle orders and sample labels.• Revamped Project management assistant position, which included hiring, training and implementing workflow improvements increasing productivity and client satisfaction.• Scheduled sample collections as per client’s approved sampling plan.• Coordinated client weekly, monthly, quarterly, and annual water plan sample compliance requirements.• Managed database with LIMS (laboratory management software) and customized reports to meet the needs of clients.

กรุงเทพฯ, Th

• Taught English as a Second Language (ESL) and Environmental Science in English to non-native speakers, improving students' language proficiency and scientific understanding.• Designed and implemented engaging English and science curricula tailored to varying language proficiency levels.• Facilitated and participated in PTA meetings to support student development and foster community engagement.• Participated in group agricultural farming projects, completing field reports and inspections.

• Oversaw and managed environmental aspects of 25-acre city property with evaluation of financial statements, sales reports, and other performance data for submission to the owner and NYC Parks Department to measure goal achievement as well as to determine areas needing cost reduction and process improvement.• Implemented soil remediation and testing of greenspace & conducted field investigations.• Oversaw NYC Parks Department environmental regulatory requirements.• Created and revamped Standard Operating Procedures to adhere to regulatory requirements.• Led monthly, quarterly and yearly P&L meetings - monitored and developed cost savings tactics, which successfully saved funds as well as prioritized spending.•Oversaw Land management and capital investment inspections, IT and network management and maintenance.• Managed 40+ employees.

Bachelor Of Applied Science - Basc, Geology/Earth Science, General

Master Of Science - Ms, Geology/Earth Science, General

Summer Course Work - Credits Transferred