Sign up to save your podcasts
Or
Share Inside Quality Management: Data Integrity, SOPs, and Regulatory Reality | CS #18
Share to email
Share to Facebook
Share to X
Share to email
Share to Facebook
Share to X
Or
Inside Quality Management: Data Integrity, SOPs, and Regulatory Reality | CS #18
In this episode of The Offer Letter – Candidate Spotlight, Brian Piotrowski sits down with Melody Trump, a quality management professional with over 15 years of experience across pharmaceuticals, nutraceuticals, and regulated manufacturing environments.
Melody shares her career journey from being the sole QC resource in small laboratories to leading QMS gap analyses, remediation efforts, and compliance initiatives as a consultant. The conversation explores the critical importance of data integrity, documentation discipline, and building quality systems that actually function in real-world operations—not just on paper.
She breaks down the operational differences between nutraceuticals and pharmaceuticals, explains when a quality system needs incremental fixes versus a full overhaul, and discusses common audit findings tied to training and documentation gaps. Melody also dives into SOP authoring from the end-user perspective, environmental monitoring program design, and how rushed implementation often creates long-term compliance risk.
The episode wraps with insights into emerging technologies like 3D printing, the evolving role of quality professionals, and why collaboration, training, and consistency are foundational to sustainable compliance.
🔗 Connect with MelodyThe Offer Letter – Candidate Spotlight is always looking for professionals who want to share their story and experience beyond a resume.
- Website
View all episodes
By Brian PiotrowskiIn this episode of The Offer Letter – Candidate Spotlight, Brian Piotrowski sits down with Melody Trump, a quality management professional with over 15 years of experience across pharmaceuticals, nutraceuticals, and regulated manufacturing environments.
Melody shares her career journey from being the sole QC resource in small laboratories to leading QMS gap analyses, remediation efforts, and compliance initiatives as a consultant. The conversation explores the critical importance of data integrity, documentation discipline, and building quality systems that actually function in real-world operations—not just on paper.
She breaks down the operational differences between nutraceuticals and pharmaceuticals, explains when a quality system needs incremental fixes versus a full overhaul, and discusses common audit findings tied to training and documentation gaps. Melody also dives into SOP authoring from the end-user perspective, environmental monitoring program design, and how rushed implementation often creates long-term compliance risk.
The episode wraps with insights into emerging technologies like 3D printing, the evolving role of quality professionals, and why collaboration, training, and consistency are foundational to sustainable compliance.
🔗 Connect with MelodyThe Offer Letter – Candidate Spotlight is always looking for professionals who want to share their story and experience beyond a resume.
- Website