Debra Daly Email & Phone Number

Greenville, NC, US

Greenville, North Carolina, United States

• Provide thorough and efficient review of scientific documents such as analytical reports, COAs, and quality events via EDMS and TrackWise.
• Cooperate with other functional teams by providing assistance and quality overview through approval and release of completed packets.
• Follow industry guidelines and cGMPs to reinforce data integrity across the company.

• Provide thorough and efficient review of scientific documents such as analytical reports, COAs, and quality events via MasterControl and eQMS.
• Cooperate with other functional teams by providing assistance and quality overview through approval and release of completed packets.
• Follow industry guidelines and cGMPs to reinforce data integrity across the company.

• Collaborated on scientific documents such as protocols, validation summaries, analytical reports, methods, COAs, SOPs, and Work Instructions.
• Conducted, wrote, reviewed, and escalated quality events/investigations as needed to reinforce data integrity across the team.
• Scheduled and planned client project work to ensure programs are kept on track.
• Mentored and guided a team of analysts with various levels of experience.

• Supported and participated in direct client interaction acting as primary interface on multiple projects.
• Collaborated with other functional teams to lead projects, assure quality and meet deliverable timelines.
• Performed a broad array of primary and advanced analytical testing methods at various stages of drug development (evaluation, validation, and stability).

• Provided technical leadership to junior analysts.
• Determined particle size distribution for MDI and DPI formulations utilizing TotalChrom for HPLC data acquisition.
• Revised methods, updated protocols and executed method optimization studies to increase testing efficiency and accuracy.
• Produced CoA and text reports for clients.

• Led multiple team oriented projects through creation of weekly schedule, effective communication of client goals, appropriate delegation of tasks, and verification of project completion.
• Participated in weekly conference calls to update client of project status.
• Received trainer certification and provided technical leadership to other analysts regarding analytical instrumentation, current testing methodologies, and proper documentation practices.
• Executed particle size determination via impactor apparatuses for MDI and DPI formulations in conjunction with HPLC analysis and Empower, Atlas, and ChemStation software.

• Conducted dissolution, assay, moisture determination, and related substances testing on solid dosage forms to support method development, method validation, stability, and release studies.
• Performed quantitative analysis of samples via HPLC and UV-Vis while utilizing Millennium, Vision 32, and Excel software for operating instrumentation, acquiring data, and reporting test results.

• Conducted the synthesis, purification, isolation, and characterization of novel organic compounds.
• Maintained detailed records as required for project team and patent purposes.