Erin Schuster Email & Phone Number

Austin, Texas, Us

Madison, Wi, Us

▪ Managed the Engineering Change Order (ECO) process utilized for RUO and IVD instruments and software by reviewing and editing associated documentation, leading review board meetings, communicating with stakeholders, driving and tracking completion of actions, and implementing changes▪ Collaborated with IT to develop a document type and process within SAP for management of declarations of conformity and performed associated software validation testing▪ Developed user requirements and test scenarios for SAP and executed associated testing▪ Authored, reviewed, and edited quality system procedures and forms, conferring with subject matter experts as needed▪ Authored blog post featured on award-winning science blog▪ Authored, reviewed, and edited nonconformance investigations, deviations, and material disposition reports and assisted with customer complaint investigations▪ Reviewed documents used in the production of instrumentation, including mechanical drawings, specifications, work instructions, and bills of materials▪ Led an initiative to complete a 2-year backlog of Engineering Change Orders (ECOs)▪ Collaborated with IT to develop a new document type and process within SAP for management of declarations of conformity and performed associated validation testing▪ Improved inspection process with Quality Control by converting hardcopy inspection drawings to electronic format and developed a process to maintain the electronic files within SAP▪ Completed a 4-day bootcamp to further develop emotional and social intelligence

Burlington, Ma, Us

▪ Advised customers and internal staff regarding compliance requirements and communicated internal practices concerning the manufacture and testing of new cGMP active pharmaceutical ingredients; addressed customer concerns and/or requests, conferring with subject matter experts as needed▪ Reviewed and edited master batch records, analytical methods, specifications, SOPs, and various protocols and reports for content, phase-appropriateness, and compliance with internal procedures and applicable regulations▪ Managed customer review and approval of documents in accordance with quality agreements and resolved customer feedback, conferring with subject matter experts as needed▪ Crafted and provided written communications to customers to notify of quality issues, such as deviations and out of specification test results, and in response to audit findings▪ Prepared and delivered presentations to customers regarding site capabilities, process validation, and mitigation actions taken to address quality issues in manufacturing▪ Authored standard operating procedures, forms, deviation reports, and corrective and preventive actions (CAPAs)▪ Released batches of cGMP active pharmaceutical ingredients following review of executed batch records and corresponding test data▪ Improved the process to create and review cGMP master batch records with a focus on overall quality and reduction in process time▪ Created and maintained a master batch record template and analytical method templates in collaboration with technical writing staff*SAFC was acquired by Merck KGaA and the company name was changed to MilliporeSigma in 2015

St. Louis, Mo, Us

▪ Maintained verbal and written communication with customers regarding campaigns to manufacture cGMP active pharmaceutical ingredients▪ Led commercial campaigns by ordering materials and maintaining inventory, creating and managing schedules, coordinating testing, and executing cGMP batch records and SOPs▪ Investigated nonconformance events and authored deviation reports, out of specification reports, CAPAs, master batch records, and SOPs

Madison, Wi, Us

• Prepared reagents, stains, and media • Autoclaved biohazardous waste and cleaned glassware• Organized, ordered, and stocked laboratory supplies • Trained new laboratory assistants

Madison, Wi, Us

Blackwell Research Group, Department of Chemistry• Investigated phenotypic and genotypic responses to bacterial quorum sensing compounds in A. thaliana• Established and maintained cell suspensions of wild type and GUS and GFP reporter strain A. thaliana

Madison, Wi, Us

Strieter Research Group, Department of Chemistry• Independently developed and conducted syntheses of peptide substructures of acyldepsipeptides• Monitored reactions and isolated products using thin layer and flash column chromatography• Collected and processed 1H NMR data

Bachelor Of Science - Bs, Biochemistry

Bachelor Of Science - Bs, Chemistry