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.• Assisted in calibrations of various instruments.• Assist management in submitting paperwork and data for new products to the FDA.• Train new employees on instrumentation and documentation.

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