• Environmental Monitoring of aseptic manufacturing environments of Grades A, B, C, D.• Proficient in non-viable, active, passive and surface sampling (RODAC, TSA, SAB, viable and non-viable air samplers).• Trained in HACH and SCADA systems for use in Aseptic Filling operations.• Cross-trained with Manufacturing Operators for better understanding and efficient operations.• Microbial analysis of Environmental Monitoring (EM) samples.• Work on shifts covering daytime/ evening and one or both weekend days.• Participate in OOS/OOE, deviation investigations, and CAPAs in a timely manner.• Knowledge of LIMS and Trackwise data systems.

• Trained in: Conductivity, Nitrates, BIs, TOC, Water Sampling, Steam Sampling, Gas Sampling, and Media Fill reads • Conduct investigations using TrackWise deviation management software regarding OOS results, procedural deviations, and CAPAS.• Write and conduct NCRs (minor and major) and Quality Events (QEs)• Perform Growth Promotion testing on incoming media requiring QAI testing in a timely matter.• Perform Bioburden testing on water and intermediate samples. • Review and revise existing SOPs and BPRs.• Maintain logbook documentation, data entry (MS Excel), and weekly/monthly cleaning of lab.

• Maintain proficiency in applying aseptic process techniques.• Follow, execute, and document batch production records and follow company and regulatory protocols as per SOPs.• Assure adequate supply of components and processing supplies to support production activities.• Ability to handle sterile components and equipment in aseptic environmental conditions.• Providing operational support for related SOP’s, Batch Records, etc.

• Recorded, analyzed, and entered data results into the SAP database.• Testing and disposition of: raw materials, resale items, reclassified products, intermediate and finished products, outgoing bulk products.• Performed the following analysis: Melting Point (Capillary Tube), Acid Value, Free Fatty Acid, Saponification Value, Saponification of Waxes, Hydroxlyl Value, Iodine Value (Wijs), Karl Fischer Moister Determination, Determination of Odor, Bubble Viscosity.

• Trained and performed: growth promotion of media. CIP/ SIP of vessels, Gram Staining and Microbial Identification.• Clean and sanitize process equipment and classified rooms as per SOP.• Assist in production of product as per BPR.