Responsibilities include but are not limited to:Editing/writing analytical method verification/validation protocols and reports, method development reports , and SOPs. Editing/writing analytical test methods. Generating technical templates as needed. Generation of consistently formatted tables, graphs, and charts. Ensuring compliance of reports and SOPs with ICH guidelines. Tracking of report milestones. Collection, interpretation, and coordination of feedback/review comments to draft final reports. Participation as needed in project team meetings. Leading the development of documentation practices.

• Raw Materials investigation team• Review/Approval of Test Methods, Protocols, and Reports• Data review

The Stability Program Administrator responsibilities include, but are not limited to:• Writing/approving/reviewing stability protocols.• Creating studies/protocols in SLIM.• Performing study maintenance in SLIM.• Ensuring that samples are placed into specified storage conditions.• Coordination of shipment of samples to and from qualified third party vendors.• Coordination of the delivery of samples to the laboratory for testing• Maintenance of the monthly stability calendar and/or other tracking information.• Staging/pulling/delivering samples for testing.• Ensuring that approved summary reports are provided to internal and external customers, and trending data.• Communication with Sponsors answering their questions, providing updates, etc

Working on SOP Harmonization between sites.Working with Empower 3 CDSTrainer

Empower SME and was a key member of the team validating Empower 3 FR4 CDS.Authored numerous SOPs including:1. 5 related to the Empower CDS validation including data integrity, usage, and online review2.Method Transfer3.Method Validation4.OOS/OOT investigationConducted Instructor led training for Empower 3 Participant in discussions regarding investigations, etc

Execute HPLC analytical method development, method transfer, method qualification, and method validation for APIs and finished products. Perform HPLC and dissolution testing. Write corresponding protocols, reports, and test methods. Interaction with clients via conference calls and e-mail. Excellent knowledge of Empower 3 Data Acquisition Software. GMP reviewer, part of team responsible for migration of documents to Novatek database. Currently a trainer for Empower, Safety and GMP review of lab techniques including HPLC, GC, Dissolution, cKF, KF, and pH.Also served as a shift supervisor and assisted QA..Very organized.

Executed HPLC and GC analytical method development, method transfer, method qualification, and method validation for APIs and finished products. Wrote corresponding protocols, reports, and test methods. Interaction with clients via conference calls and e-mail. Trained new employees and informal supervision of workflow..

Safety committee member, Executed HPLC analytical method development, method transfer, method qualification, and method validation for APIs and finished products. Wrote corresponding protocols, reports, and test methods. Interaction with clients via conference calls and e-mail. Prepared SOPs and LDEV/LIRs. Member of the Millennium Data Acquisition Software improvements team. Trainer for method development, method validation, HPLC, dissolution testing, Millenium Data Acquisition software, and other lab related modules. GMP reviewer.

Taught Basic Chemistry and designed laboratory experiments

Provided QA support for USEPA air monitoring program through sample preparation and analysis. Conducted audits of USEPA air monitoring sites. Authored SOPs and Test procedures as well as the technical section of contract proposals

Development of HPLC and GC analytical methods for agricultural products such as pesticides and insect growth regulators. Troubleshooting of manufacturer process problems such as waste stream pretreatment. Trained lab personnel and production personnel. Member of corporate safety committee. Participant in monthly analytical discussion group