Jennifer James

• Work closely with all functions, including Program Management, Product Engineering, Quality Engineering, Procurement, Marketing, Logistics, etc. to lead all Change Requests from inception through to Change Implementation.

• Monitor, update and implement engineering requests in Arena PLM system.

• Process requests and changes in support of activities for all aspects of the Product Development Lifecycle.

• Manage
execution of engineering changes end to end from inception of change request, collation of inputs, impact analysis, to approval, implementation, and communication of changes.

• Collaborate with stakeholders from Engineering, Manufacturing, Supply Chain, and Quality functions to understand engineering change requests, gather required input, and facilitate change implementation.

• Coordinate with team members, suppliers, and vendors, to ensure project requirements and time bound activities are being met.

• Manage APR (Alternate Part Request), PCN (Part Change Notice) and EOLC (End of Life Component Notice) programs.

• New part number creation management.

• BOM creation and configuration management utilizing Arena (PLM). Conduct BOM audits to ensure releases are accurate.

Process

• Enforce strict adherence to rules for complex BOMs, documentation, revision, version and material disposition.

• Drive the continuous improvement of Change Control and Document Control processes.

• Work with key stakeholders to identify change barriers and devise strategies to overcome challenges.

• Evaluate proper ECR/ECO submittal ensuring internal and external customer compliance. Ensure accuracy of design changes for conformance and correctness to standards.

• Create new process and procedure documentation relating to product lifecycle and engineering change control.

Documentation

• Process Change Management Files according to procedure(s), ensuring appropriate formatting, document classification, cross references, and approvals, in Arena PLM system.

• Audit Change Requests (CRs – PRCRs & ECRs) and Notifications to assure proper revisioning process, release procedures are being followed.

• Review modifications of engineering drawings using Solid Works

• Act as a liaison with Engineering, Marketing, Sales, Shipping, Regulatory, Quality and Manufacturing to control, issue, and update documents used in the PLM system.

Project Management

• Schedule and conduct regular meetings with department teams to ensure all changes are on track for implementation.

• Works effectively with project managers to support their efforts in managing projects for success.

• Working knowledge of project management and process improvement discipline and tools and ability to integrate change management deliverables in line with project needs.

• Employs proven methodologies and best practices to ensure consistent and repeatable change management approach is embedded in program(s) and projects.

Training

• Provides training on change management to all departments, including outside vendors and suppliers as needed.

• Present and explain subject matter to people with different skills and background.

• Conducts Arena PLM system training for Users.

•Educated taxpayers and/or their representatives regarding tax obligations, responsibilities, rights, and options, including possible adverse consequences of decisions. Fully advises taxpayer of all rights and, as applicable, secures agreement of taxpayer to final decision.
•Applied laws, rules or regulations and written guidelines; communicating orally to provide information, assistance, or instructions to individuals.
•Performed specialized research, analysis, and necessary computations to make adjustments to taxpayers' accounts that have specialized factors. Using highly developed institutional knowledge of internal processes, solves vexing process and procedural problems of cases.
• Demonstrate a basic knowledge of IRS tax procedures, policies (rules and regulations), and tax forms to assist customers in the resolution of account inquires;
•Conducted personal or telephone interviews with a wide range of individuals who have varying degrees of understanding of tax law and procedure.
•Provided full explanation to specific inquiries initiated by an individual, generated by notices or internally generated assignments.

• Responded to inquiries from taxpayers regarding their accounts or payments due.
• Performed calculations necessary for determining a taxpayer's taxable income and liability amount.
• Negotiated payment plans with delinquent taxpayers when needed.
• Participated in training sessions designed to stay abreast of current tax laws.
• Researched legal decisions pertaining to taxation matters as needed.
• Discussed and explained various tax forms with taxpayers.

· Demonstrated ability to effectively lead cross-functional/cross-plant project teams using relevant project management tools such as Microsoft Project

· Demonstrated experience in design and development of training programs/courses; and lean documentation

· Performed internal quality assurance audits to 21CFR 820, ISO 13485:2003 and other applicable standards to ensure corporate and regulatory compliance

· Responsible for administration and coordination of daily processes, which resulted in the establishment, improvement and maintenance of the Quality Management System

· Established quality requirements of external suppliers; conducting or overseeing supplier qualification audits

· Experience with Catalyst ERP system

· Managed the Change Control Program (including labeling, Bill of Materials and specifications)

· Implemented systems to assess adequacy and effectiveness of the QMS

· Oversaw the implementation of an effective Corrective Action program to prevent reoccurrence or occurrence of quality problems

· Managed CAPA and MDR database, investigation and closure

· Managed regulatory team

· Develop and maintain GMP SOPs, controlled documents, and master documents including labeling, bill of materials, DHF and DMR

· Established and managed customer focused complaint tracking system

· Organized and maintained equipment and instrument calibration programs

· Successfully organized and prepared electronic submission of pre-IDE and subsequent 51OK to FDA

· Established and maintained technical report database utilizing JabRef.

• Managed library of both electronic and paper documents according to ISO, FDA and cGMP guidelines
• Reviewed, updated and wrote new SOP's to reflect current procedures
• Trained all employees on procedures and regulations utilizing classroom and computer based training methods
• Manage routine quality assurance needs associated with manufacturing and testing of APIs and stability of finished pharmaceuticals
• Tracked all clinical supply inventories and manufacturing runs
• Tracked all CMC contractual obligations against work completed
• Maintained approved vendor list, and performed site audits
• Collected CMC data and documentation to support all regulatory activities per US and EU requirements
• Assisted with editing and review of CMC sections for INDs, BLAs and CTDs (Foreign and Domestic
• Developed and implemented a Quality System for CMC Technical Reports
• Maintained Drug Master Files for all drugs in pipeline
• Created and maintained technical report database utilizing JabRef as well as a reference library space
• Responsible for the organization and formatting of the CMC section of NDA submissions, pre-approval inspection audits and for IND/CTA/IMPD submissions worldwide.

• Provided all regulatory clinical research related support.
• Participated in the authoring of SOPs and Wls governing clinical operations and study records management.
• Trained all employees on procedures and regulations, utilizing classroom and computer training methods. Maintained training records and database.
• Ensured Quality System compliance by performing internal audits and reporting to upper management.
• Authored site regulatory binder for numerous protocols.
• Performed site visits; initiated onsite queries, reviewed source documents, diaries and all study related documentation.
• Applied knowledge of Code of Federal Regulations (21 CFR), ICH/GCP guidelines to complete tasks required to support the clinical trial.
• Responsible for management of all clinical study trial master files and all project working files.
• Worked with CRO contracts, invoice review and reconciliation. 10. Developed plan for organizing and formatting electronic NDA submission.