Job Description:

General Responsibilities:Quality Assurance is a support group to the Operational Departments of Manufacturing, Quality Control and Facilities. The Quality Assurance System Administrator interacts with all functional groups in the organization to ensure compliance to policies and procedures, in addition, assures accurate and compliant release of intermediates and final product.Responsibilities:Primary responsibility will be to build and enhance Workflows in all the Modules within MasterControl (Document, Training, CAPA, Deviations, Change Control, Vendor Management and Audits)Manage data structure.Create lifecycles within MasterControl to manage organizers, create templates, virtual folders, document numbering series and custom reports. Configure InfoCard types and Subtypes, Global Settings, Collaboration steps, Packet Types, as necessary to meet business needs.Troubleshoot errors. Design E-FormsFillable forms within MasterControl for use by personnel.Manage user licenses and user security settings.Conduct annual validation of MasterControl (PQ), submit subsequent report to MasterControl to meet deadlines.Train employees in use of MasterControlWrite and revise Quality Systems and MasterControl related SOPs as necessary to maintain compliance.Assist the Quality Assurance Management in daily operations, as needed:Review Manufacturing Batch Records (Drug SubstanceDrug ProductMedia Fills Prepared Media and Protocol Records). Review and disposition of manufactured Bulk Drug Substance and Drug Product Injection lots. Records to be reviewed for accuracy, completeness, and compliance with effective SOPs.Review of Quality Control testing data against established specifications for compliance.Manage Deviations, Change Controls and CAPAs to closure. Conduct risk-based investigations using problem solving tools.Review equipment CalibrationPM recordsReview Computer System Validation records Represent Quality Assurance in Management Review Meetings, Material Review Board Meetings and in continual improvement projects as they relate to the Quality Management System and MasterControl.Participate in Regulatory Agency Inspections, as puter Skills: Competency with electronic Quality Management System software (i.e., TrackWise, MasterControl, QT9, Qualio etc.) To perform this job successfully, an individual should have knowledge of Database software; Project Management software; Spreadsheet software and Word Processing software.Education: Minimum Bachelor of Science degree in a scientific disciplineExperience:Minimum two years in a similar Quality Assurance or Quality Systems role in the biologics or pharmaceutical industry a plusFamiliarity with 21CFR Part 210, 211, ISO 9001 Std. and ICH guidelines is considered a plus.Familiarity with Quality Management Systems (e.g., ISO9001ISO1485 Std.)Familiarity with Batch Records and controlled documentation Experience in aseptic processing and mammalian cell culture production considered a plus.Other Skills:Detail orientedGood verbal and technical writing skillsGood interpersonal communication skills Must be open to occasional off shift and weekend work.Positive work attitude that supports teamwork and continuous improvement