Dilsis A. Email & Phone Number

Plainsboro, New Jersey, United States

• Ensure regulatory compliance (GMP, FDA, ISO 9001, CMDR, Medical Device Directive) for labwork, documentation, and stability programs.
• Conduct system suitability tests on SEM instrument samples.
• Manage sample shipments, monitor trends, and prepare stability trend reports.
• Conduct wet chemistry testing, draft investigation reports, and contribute to QC improvement projects including test method development and 6S implementation.
• Successfully coordinated the addition of new lab instruments, collaborating with multipledepartments and vendors, while spearheading communication efforts for seamlessimplementation.

Philadelphia, Pennsylvania, United States

• Ensured compliance with GMP and FDA requirements for laboratory work, documentation, andinvestigation documents.
• Conducted testing on Raw Material samples using wet chemistry methods, GC, and followingSOPs for data interpretation.
• Managed procedures, protocols, change controls, SOP revisions, and test method updates.
• Trained new employees on instrumentation, documentation, and adherence to SOPs.
• Assist with instrument calibrations on various instruments.
• Open change controls, and generate and revise SOPs and test methods.

Buena, New Jersey, United States

• Ensure compliance with GMP/GLP and FDA requirements for documentation and laboratorywork.
• Review data packets, change controls, investigations, and instrument calibrations.
• Contribute to Method Transfers for injectables, ensuring transferability to QC testing throughcollaboration with R&D.Assist with opening, and closing deviations, and investigations.
• Enter, review, or approve all data in LIM.S
• Perform testing on in-process, raw materials, finished product, and stability samples using avariety of wet chemistry methods, GC, and HPLC.
• Calculate and interpret data according to standard operation procedures.

Bethlehem, Pennsylvania, United States

• Conduct testing on in-process, finished product, and stability samples using wet chemistrytechniques and GC.
• Manage the stability program, including sample acquisition, storage, testing examination, andrecord-keeping.
• Assist in instrument calibrations and collaborate closely with production to acquire data forfuture batch creation.
• Follow GMP/GLP, USP, EP, JP, and FDA requirements with documentation andlaboratory work
• Perform testing on in-process, finished product, and stability samples using wetchemistry techniques, and GC