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.

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.

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.

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 &.
• 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.

• 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.
• 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.

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

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

Summer Course Work - Credits Transferred