Robin Knott Email & Phone Number

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.
• 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.
• 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.
• 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.
• Coordinating and participating in gap assessments of Quality systems

• 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.
• 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

• 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.
• 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

• 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

• 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