Crystal Beer Email & Phone Number

Madison, Wisconsin Area

Madison, Wisconsin Area

Responsible for on-going Quality programs, corrective and preventive action, change control, Device History Record review and lot releases, equipment qualification, and continuous improvement.

Madison, Wisconsin Area

Madison, Wisconsin Area

Madison, Wisconsin Area

Document Management:●Assign and release change orders.●Aid in the recording of material inventory and retention.●Organize change order, SOP, and regulatory documentation.

Madison, Wisconsin Area

Labeling:●Labeling specialist: Ensuring company's labels on test equipment and products meets or exceeds all regulatory standards (FDA/ISO/CE).●Interfaced with regulatory consulting companies for international product submissions.●Maintain templates for use on labeling documents for new and existing products.Training and Project Management:●Training new employees on the Quality System requirements.●Training departmental employees on job responsibilities.●Participated in projects using Six Sigma and Lean Principles.●Assisted in the creation of project timelines for new products and for the transition of products to new manufacturing site.Document Management:●Super user in Document Control Software: TrackWise, Master Control, and Agile Quality Systems.●Assisted in the drafting of validation protocols and review of development DHR files and materials.●Document Control responsibilities: Update, revise, review, and assist creating documents, (SOPs, Work Instructions, labels and templates) with emphasis on quality, regulatory standards and GMP compliance.Quality Assurance Batch Review:●Quality Assurance approval on batch records and incoming materials.●Interfaced with internal and external audit teams to demonstrate compliance with regulations and quality system standards.

Labeling specialist: Ensuring company's labels on test equipment and products meets or exceeds all regulatory standards (FDA/ISO/CE)Super user in Document Control Software: TrackWise, Master Control, and Agile Quality SystemsQuality Assurance approval on batch records and incoming materialsDocument Control responsibilities: Update, revise, review, and assist creating documents, (SOPs, Work Instructions, labels and templates) with emphasis on quality, regulatory standards and GMP complianceInterfaced with regulatory consulting companies for international product submissionsInterfaced with internal and external audit teams to demonstrate compliance with regulations and quality system standardsParticipated in projects using Six Sigma and Lean Principles

Revised labels on over 1000 items to align all products with regulatoryrequirementsConsistently revised Work Instructions to align with new labeling requirementsAssisted in design of templates for use on labeling documents for new productsWorked closely with senior regulatory team member to enforce compliance toregulations (FDA, ISO, and CE Mark) in a GMP facility.

Assisted in lab preparation and filling chemical suppliesEnforced the use of safety equipment in the labIssued student suppliesChemical spill responder for small spills

Inventory Control : Ordering, receiving, cataloging and stocking suppliesInitiated, and completed store job manual