Cheryl Gonzalez Email and Phone Number

Perform documentation verification such as SOPs, Test Methods and Specifications for multiple departments.Approve and promote documents in EDMS / D2 system.Work with periodic reviews in EDMS / D2 and Global TrackWise.Administer FileTrail System for secure documents archiving.Administer logbooks creation, review, reconciliation and archiving.Release of Master Batch Records in JDE and POMS.

Develop, execute and document CSV life cycle documentation (IOPQ, URS, etc) for manufacturing and environmental monitoring.

Analytical data review for Raw Materials, Finish Product, Validations and Stabilities.Performed robust laboratory investigations through Root Cause Analysis evaluation.Analytical execution, documentation and report to stakeholder execution schedule and outcome of test methods transfer, compendial verification and validation.Evaluate analytical methods and perform analytical development and/or investigational experiments.QC laboratory analytical sample testing, solutions preparations and documentation.Interpret and document analytical data through Empower data acquisition system. Support Empower creation of Instrument Methods and Custom Fields for Methods transfer and/or new methods.

Develop, execute and document Installation, Operation and Performance Qualification (IOPQs), Performance Qualification and Final Reports for laboratory High Performance Liquid Chromatography System (HPLC), Ultra Performance Liquid Chromatography System (UPLC), Gas Chromatography System (GC) and Particle Size Analyzer (PSA).Develop and document Standard Operating Procedures (SOPs) for each new system.Administered trainings related to laboratory Systems (HPLC, UPLC, GC and PSA) and Empower 3 Chromatography Data System (CDS).Provided technical advice for the qualification of Empower 3 Chromatography Data System (CDS).

Develop cleaning validation protocols, perform cleaning samplings (swabbing) in the Packaging and Manufacturing areas for equipment release.Provided technical advice on the design and assisted in trainings of the cleaning validation exercises.Develop, execute and document, Installation/Operation Qualification (IOQs), Performance Qualification (PQ) and Final Reports in the Packaging and Manufacturing areas for equipment release.

Gap assessment of the Analytical Method developed validated by the company’s Research and Development Department which requires a Karl Fisher System.Develop a series of testing to verify the accuracy of the equipment, Feasibility Study and Report.

Develop, execute and document Standard Operating Procedures (SOPs), Design Qualification (DQs), Installation/Operation Qualification (IOQs), Performance Qualification (PQ) and Final Reports for different equipment qualification such as Disintegrators, Air Sampler and Water Activity Meter.

Develop, execute and document Standard Operating Procedures (SOPs), Design Qualification (DQs), Installation/Operation Qualification (IOQs), Performance Qualification (PQ) and Final Reports for different equipment qualification.

Analytical execution, documentation and report to stakeholder execution schedule and outcome of test methods transfer and validation activities for new products.Evaluate analytical methods and perform analytical development and/or investigational experiments.Performed laboratory investigations. Root Cause Analysis evaluation, CAPA and Change Control evaluation, execution and implementation.Interpret and document analytical data through Empower System 2 and 3. Support Empower creation of Instrument Methods and Custom Fields for Methods transfer.Maintenance, calibration and qualification of laboratory equipment such as Balances, pH Meter, Waters High Performance Liquid Chromatography (HPLC), etc.