•Provides direct quality support to numerous E2E IPT’s ensuring product/process quality and facilitating the release of product to the market.• Responds to environmental events that have occurred in the classified areas and provides the appropriate response guidance (cleaning, EM requalification, deviation initiation, etc.) and manages cross-functional partnerships required in response to the events.• Authors, reviews, and approves routine and event-based environmental related project protocols, reports, special studies, and data assessments (including performing/interpreting trending results). Additionally, manages projects for process simulations in the manufacturing areas. •Authors, reviews, and approves risk-based assessments, including updates/creation of EM test site maps, change requests, shop floor walkthroughs, and data analysis queries.• Partners with Quality and associated IPT to implement continuous improvement initiatives to better sustain environmental control.• Leads other EM Quality Specialists and assists with training and coaching of incoming and/or cross functional personnel.• Reviews daily Out of Specification Report for EM results and collaborates with the associated IPT and deviation management team to address environmental excursions.• Supports contamination events as necessary, which includes providing environmental control input, data trending and analysis, and authoring special studies.• Supports and participates as necessary with internal/regulatory inspections.• Leading the per-process testing implementation project for the PV E2E.

•Provides direct quality support to numerous E2E IPT’s ensuring product/process quality and facilitating the release of product to the market.• Responds to environmental events that have occurred in the classified areas and provides the appropriate response guidance (cleaning, EM requalification, deviation initiation, etc.) and manages cross-functional partnerships required in response to the events.• Authors routine and event-based environmental related project protocols, reports, special studies, and data assessments (including performing/interpreting trending results). Additionally, manages projects for process simulations in the manufacturing areas.• Authors, reviews, and approves risk based assessments, including updates/creation of EM test site maps, change requests, shop floor walkthroughs, and data analysis queries.• Reviews daily Out of Specification Report for EM results and collaborates with the associated IPT and deviation management team to address environmental excursions.• Supports and participates as necessary with internal/regulatory inspections.

-Performs installation and calibration of thermocouples and dataloggers to measure and record thermal data-Utilizes Kaye Validator software, Kaye Valprobe software, and other pressure/temperature dataloggers for the qualification of autoclaves, dry heat ovens, and tunnels (including SIP)-Installation and aseptic retrieval of biological indicators for qualification activities-Generates data summary printouts, graphs of thermal data, data packs, and deviation summaries-Utilizes SAP/work orders to ensure activities are documented as per procedure

Performed all time sensitive testing including sterility and bioburden that are used to evaluate microbial presence in a sample . Trained to perform environmental monitoring plate reading, review, and microbial identification. Acted as the safety correspondent for a large group with responsibilities including: actively tracking safety incidents, updating the risk map, developing and implementing CAPA's for safety incidents, and relaying monthly safety cascade. Trained numerous employees on testing methods within the department. Supported the department by revising documents and authoring deviations. Pioneered process improvement ideas using LEAN concepts.

Quality Control testing for the Microbiology department including: Influenza Plate Count, Bioburden, and Sterility testing using a La Calhene chamber and isolator. This involved working with BSL2+ organisms at times (aseptically gowning). Other duties include: environmental monitoring plate reading, aseptic process simulation reading, and participating in deviation write-ups. All samples are 24hr time-sensitive tests so working together with the team is crucial.