Grisel Rivera Batista Email & Phone Number

Manati, Puerto Rico

• Managed changeovers and implementation activities for manufacturing processes.
• Led quality and safety investigations/CAPAs related to customer complaints, rejected batches, and quality incidents within cross-functional teams that involved Technical Services, Operations, and Quality Assurance.
• Provided process instructions documentation, standard operating procedures, and training to Operations team.
• Directed first-party quality and safety audits within manufacturing and quality control areas to ensure process complied with IATF 16949.
• Collaborated with R&D to complete new product introductions through Manufacturing Acceptance Reviews.
• Performed Material Review Board within Quality Assurance and Engineering Science team to evaluate potential risks of materials involved in process deviations in alignment with pFMEA and control plans.

Barceloneta, Puerto Rico

• Managed generation and implementation of reaction plans in manufacturing lines of medical devices as part of Zero Defects Global project.
• Liaison between suppliers and operations to resolve quality issues related with components used in the manufacturing lines.
• Provided technical support for supplier quality investigations that impacted manufacturing lines.
• Communicated and reviewed project updates and results within leadership and Global Quality Team.

Juncos, PR

• Participated in development, review, and approval of deliverables, such as process investigations, product impact assessments, and process transfer documents.
• Provided manufacturing support by monitoring through SIMCA-online, PI Process Book, OVDAS SAS, and TIBCO™ Spotfire systems.
• Authored and verified reports supporting process development and manufacturing operations, including process performance qualification protocols, investigation reports, and technical assessments.
• Participated in execution of bridging studies for analytical testing in process development and scale-up laboratories.

Carolina, PR

• Supported biotech process by performing impurities and protein concentration analysis to fermentation and purification samples by HPLC Reversed Phase.
• Conducted potency and LOD analysis to fermentation samples by HPLC and microwave techniques.
• Coached and trained colleagues in routine in-process testing, including HPLC, moisture analysis, and swabs.

Cambridge, MA

• NSF Harvard REU Summer ProgramPrincipal Investigator: Eric Mazur PhDResearch Advisors: Jonathan Bradley PhD / Christopher Evans PhD
• Investigated laser damage threshold of TiO2 for on-chip nonlinear nanophotonic devices applicability.
• Characterized nanophotonic materials by Raman, SEM, and UV-vis spectrophotometry.

Menlo Park CA

• US Department of Energy - SULI ProgramResearch Advisors: Sumohan Misra, PhD / Michael F. Toney, PhD
• Worked in the Stanford Synchrotron Radiation Lightsource at SLAC.
• Crystal structure characterization of bulk and nanomaterials through Anomalous XRD.

Bachelor Of Science - Bs, Chemistry

Bachelor Of Science (Bs), Chemical Engineering

Master'S Degree, Engineering Management - Manufacturing Management