Robin Knott Email & Phone Number

Chapel Hill, Nc, Us

Chapel Hill, Nc, Us

Stamford, Connecticut, Us

San Diego, Ca, Us

Somerville, Massachusetts, Us

Dublin, Ireland, Ie

Providing support to the Quality Assurance department by:• Performing dispositioning activities, including: o Utilizing inventory management system (BPCS) and other associated Quality systems, e.g.,TrackWise, to ensure proper release of finished product for the Raleigh manufacturing site o Reviewing and approving Certificate of Analysis documents for finished product and by-products• Providing customer service and acting as a liaison for product related external customer inquiries o Primary point of contact for the Raleigh manufacturing site for technical inquiries/requests including product statements and GMP related documentation, e.g., product specifications, CoAs, testing/methods, stability data, GMP compliance, raw materials/stability/storage & transport questionnaires, audit requests, etc.• Acting as Audit Lead for on-site and virtual customer audits, and internal Corporate audits, and as Inspection Coordinator for regulatory authority inspections o Scheduling audits and coordinating all associated activities, including, but not limited to, utilization of virtual meeting software (WebEx, Skype for Business) and a Web Transfer Client for virtual audits; performing a virtual audit tour; and preparation of all audit related documentation, presentations, storyboards, etc. o Maintaining Site Inspection Readiness Program o Created Site Inspection Readiness SOP o Created Site Inspection Readiness Plan• Providing management updates and performing presentations to management regarding metrics and department performance during operation review meetings, e.g., customer and Corporate audit metrics, regulatory inspection metrics, and customer inquiry metrics • Coordinating and participating in gap assessments of Quality systems • Owning and managing Quality related change controls

Provided support to the Quality Assurance Operations department by:• Supporting disposition for starting materials and manufactured products• Reviewing and approving documents including: Manufacturing batch records in support of product release; Standard Operating Procedures, Process Validation Protocols and Reports ensuring all documentation complies with cGMP regulations and industry guidelines• Supporting Manufacturing Operations during batch production, ensuring unexpected events are handled compliantly and in a timely manner• Preparing and reviewing documents associated with deviations, investigations, OOS results, and CAPA action plans• Performing Shop Floor QA activities: line clearances, area release, GMP walkthroughs• Supporting regulatory inspections and internal audits• Supporting batch execution metrics, providing input to Management – alignment to target Turnaround Times and Disposition dates, number of comments and deviations per batch• Identifying quality issues and effectively and proactively resolving them in a diplomatic, flexible, and constructive manner • Performing data review, analysis, and identification of trends, and complex problem solving

Provide support to the Quality Assurance department by:• Reviewing and/or approving of GMP raw data for compliance and GMP documentation to support batch disposition, e.g., cGMP procedures, Master Production Records, Solution Lot records, BOMs, Formulas, and Process Automation reports • Reviewing and/or approving protocols and technical reports, including but not limited to investigation reports and QC in-process trend results reports • Reviewing/approving deviation investigations (root cause analysis/impact assessment), corrective actions/preventative actions (CAPAs), and Change Controls• Identifying gaps in existing Quality systems and proposing/implementing solutions to Quality systems• Aiding in technical problem solving (tools or enterprise systems) across multiple functional areas• Controlling and releasing of equipment from maintenance, validation, change control and product changeover• Teaching GxP Quality systems-related training (including Performing Investigations classroom training)• Performing batch disposition• Participating in internal audits, including performing monthly warehouse and dispensary area walk-throughs

Provide Support to the Manufacturing Sciences (MS) department by:• Drafting/editing and routing of electronic technical documents including, but not limited to, process validation protocols and reports, trend reports, technical memos, and Process Flow/Control Diagrams • Managing/owning Global process Change Controls • Creating and/or revising SOPs and global directives in support of technology transfer, container closure, and process validation• Gathering and verifying data for technical reports, e.g., process validation and campaign summary utilizing various data systems • Managing/owning technical process deviation investigations to ensure robust root cause identification and corrective action or preventative action (CAPA) implementation • Preparing impact assessments for process related deviations• Providing support during site audits• Creating and maintaining a database of MS owned process validation documents • Training/aiding co-workers in use of Oracle PLM, TrackWise, Discoverant, SharePoint, and DocCompliance• Managing department training curriculum and compliance

Provide Support to the Manufacturing Sciences (MS) department by:• Drafting/editing and routing of electronic technical documents, including but not limited to, process validation protocols, trending reports, technical memos and Process Flow Diagrams • Managing/owning Global process Change Controls• Creating and/or revising SOPs and global directives in support technology transfer, container closure and process validation• Gathering and verifying data for technical reports, e.g., process validation and campaign summary, utilizing various data systems • Provide support during site audits

B.S. Industrial Technology, Bioprocess Manufacturing

Pharmaceutical Sciences

Associate Of Applied Science (Aas), Bioprocess Technology