Brian B. Email & Phone Number

Dedham, Ma, Us

Somerville, Massachusetts, Us

Somerville, Massachusetts, Us

Somerville, Massachusetts, Us

Somerville, Massachusetts, Us

Amsterdam, 1105Bp, Nl

Provide on-the-floor support of cGMP gene therapy manufacturing operations for Upstream, Downstream, and Drug Product filling processes.Quality Assurance review and approval of Batch Production and Solution Lot Records.Create, review, and approve labeling of buffers for release to support manufacturing operations.Adhere to label specifications for clinical use globally.Continuous Improvement of manufacturing operations through use of Quality Systems.Initiate, review and approve CAPAs/Deviations.Initiate, review and approve Change Controls.Initiate, review and approve document changes to Standard Operating Procedures and Forms.Support internal audits, including on-the-floor walkthroughs of the MFG facility.Review and approve logbooks used during manufacturing operation of Biosafety Cabinets, Bioreactors, and Freezers.Review and approve release of raw material.Liaison between Quality Assurance and Manufacturing stakeholders.Provide daily observation reports of manufacturing operations; requesting initiation of deviations when needed.Quality Assurance support for requalification of Drug Product filling machine.

Waltham, Ma, Us

Support the Quality Assurance Compliance Department oversight of all cGMP internal and external manufacturing operations by performingReview and approval of Internal and External DeviationsQuality review and approval of Change Controls.Review and approval of Document Change Controls.Compliance querying in support of Product Disposition.Provide support to product disposition by reviewing Finished Goods batch records and applicable documentation Lead for IT system implementation of GxP systemsReviewer and approver of Protocols and Reports and at times performed UAT Testing in support of the project.Support and perform Product Complaint investigations, trending and reportingSupport internal/external audits, including Health Authority inspections and interactionsEnsure team and stakeholders maintain inspection readiness. Lead for Legacy Change Control Migration into Sanofi Change Control Management systemManaged team assignments.Supported LIMS implementation Executed Validation test scripts.Performed review and approval of Master Data Request for LIMS builds.

Marlborough, Ma, Us

Leading Document Control integration of Cosman Medical into the Boston Scientific Quality Management System (QMS) using Windchill and WebXtender.NCEP and CAPA investigation and support, proficient with eCAPA.Technical writing of procedures for medical device Quality Systems.Administer Design History Files (DHF), Device Master Records (DMR), Return Material Authorizations (RMA), and Complaints as needed.Receive, Scan, and Migrate DMR in Windchill through a defined Change Notice process.

Marlborough, Ma, Us

Administer Arena PLM Document Management System including adding/modifying user privileges as required. Process Electronic Change Orders (ECOs) and Change Notices (CNs) in Arena and Windchill Document Management Systems. Remediation of Quality Records due to site integration activities in relation to a CAPA.Indexing and maintenance of Quality records including Lab Notebooks, CAPA and non-conformance records, training, equipment, clinical studies, management review records, internal audits, etc.Investigation of equipment controls CAPA involving mis-alignment of preventative maintenance (PM) and calibration scheduling requirements.

Bachelor'S Degree, Economics

Bachelor'S Degree, Pharmaceutical Business