InnovaWorkforce Inc.
- Integrate Outbound scheduling with Control Tower booking by managing all high-profile shipments.
- Assure most efficient and reliable tendering so booking is tendered acknowledging agreed pricing minimizing surcharges.
- Partner with outbound scheduling to allocate capacity on to assure most efficient flights.
- Audit E2E high profile shipments tender to invoice to assure that charges are accurate.
- Main point of contact for all enVista affairs
- Assure target efficiencies of $5.5 MM in 2022
- Ability to navigate in a matrix environment with strong internal and external network relations.
- Good understanding of GMP/GDP and pharmaceutical regulations and awareness of biopharmaceutical commercial and supply chain trends and developments.
- Ability to analyze abstract and complex problems requiring evaluation of intangible variables.
- Ability to develop innovative and creative output based on interoperations and analysis
- Deep understanding of E2E supply chain business processes (APCIS CPIM, SCOR, S&OP, Logistics, Customer Service).
- Demonstrated success in Operational Excellent, Lean, PULL and major change management initiatives.
- Experience in working in an international environment, ability to liaise/communicate effectively with cross-functional teams and different cultures.
- Ability to develop insightful strategies based on knowledge or external and internal operating environment.
- Solid experience in project management across departments and geographies.
- Readily adapts to and manages change.
- Good decision making skills.
- Customer relationship skills.
- Process improvement and leadership skills focused on implementing robust, efficient systems & processes.
- Quick process understanding, insight and visualizing.
- Fluent in English, both in verbal and written communication.
- Strong analytical skills (incl. MS Excel) and ability to distill insights.
- Operational Excellence experience or training.
- Preferred LEAN Six Sigma
The Transportation Specialist is responsible for maintaining and executing controlled environment logistics and transport validation processes by: Owning and managing NCs, CAPA and site/global Change Controls. Conducting transport validation assessments for change controls. Drafting and executing Transport Validation Master Plans, Operational Qualifications and Performance Qualifications protocols and author reports to meet product commercialization milestones, including regulatory filings deadlines. Coordinating and participating in risk assessments and author summary reports. Drafting and executing transport lane characterization protocols and author reports. Maintaining lane characterization data repository. Measuring cold chain process metrics and key performance indicators. Partnering with network members and key functional areas to problem solve and implement global cold chain solutions to reliably deliver materials and products to global supply chain points. Implementing and executing current good shipping/distribution practices to ensure compliant transport process. Continuously improving transport process procedures to maintain compliance and effectively support product transfer and commercialization. Continuously growing knowledge of industry practices. Implement distribution projects that support the regions strategic plans. Work cross functionally by establishing new supply routes, supply sites, distribution models. Manage cold chain supply chain compliance. Build financial justification distribution models. Serve as Distribution Subject Matter Expert for audit of third party distribution partners (Logistics Service Providers, carriers and distributors). Partner with Global Logistics to share best practices and gain alignment. Conduct monthly report on Transportation performance and drive improvements. Manage third party distribution partners (LSP, carriers and distributors) to meet Service Level agreements. Use Operational Excellence as an approach to driving continuous improvement in performance and cost reduction distribution strategies. Manage all aspects of project(s): planning, implementation, monitoring, completion, and follow-up. Manage competing timelines and prioritize critical tasks. Establish and achieves project standards for work quality and quantity. Identify and anticipate schedule slips or changes and analyzes the costs, resource and compliance impact. Implement tools, techniques and processes to provide or create information to enable informed decision making within the teams. Identify or lead focus area projects within the overall function of project management or related projects. Generate periodic updates and prepare formal presentations for required forums. Generate individual and more complex reports utilizing various resources. Ensure project work complies with domestic and international regulatory requirements and approved guidelines relevant to area of responsibility. Ensure project work complies with practices, policies and standard operating procedures. Participate in required meetings, activities, and related projects and relevant interdepartmental activities. Anticipate resource needs and communicate to management sponsors. Responsible for setting up transportation lanes and in conjunction with Quality owns decisions regarding the set up and assessment of transportation lanes originating from the site. Generates and approves the assessment reports in EDMQ. Manage transportation carriers Perform transportation investigation, when applicable. Authors, reviews and/or approves documentation with system qualification activities in accordance with Corporate and site procedures Translate transportation regulations and Amgen SOP’s to executable programs Develop SOP and training programs developed according to new transportation regulatory requirements. Direct and coordinate daily activities of personnel responsible for material receipt, storage, distribute and transport. Ensures materials are received, stored and transported/shipped according to established performance standards and all applicable procedures and regulations. Interacts with internal and external regulatory agencies to ensure compliance with cGMP, GDP, IATA, DOT,OSHA requirements. Collaborate with other sites to maintain optimal flexibility for the storage of all materials and product. Identify and oversee implementation of new and improved business and compliance systems and tools. Partner with key internal customer groups and/or external suppliers to ensure successful operations and performance targets are achieved. Responsible for business continuity programs for assigned areas. Participate on global functional teams to coordinate and improve the transportation and Logistics of material movement and storage across the company Supply Chain. Direct and coordinate daily activities of personnel responsible for developing and managing Product demand and forecasts. Organize and communicate on a regular basis the total demand and supply requirements to senior management. Manage the process of gathering, evaluating and feedback of global distribution requirements. Provide and coordinate the development of business case scenarios that demonstrate the impact of current or proposed operations plans.? Manage the preparation and communication of the Company wide Inventory Distribution Plan to achieve corporate goals of customer satisfaction and risk management. Responsible for setting up transportation lanes and in conjunction with Quality owns decisions regarding the set up and assessment of transportation lanes originating from the site? Authors, reviews and/or approves documentation with system qualification activities in accordance with Corporate and site procedures? Translate transportation regulations and SOP’s to executable programs? Owning and managing NCs, CAPA and global Change Controls. Drafting and executing transport lane characterization protocols and author reports. Maintaining lane characterization data repository.? Measuring cold chain process metrics and key performance indicators. Partnering with network members and key functional areas to problem solve and implement global cold chain solutions to reliably deliver materials and products to global supply chain points. Implementing and executing current good shipping/distribution practices to ensure compliant transport process. Continuously improving transport process procedures to maintain compliance and effectively support product transfer and commercialization. Continuously growing knowledge of industry practices.
Basic Qualifications Doctorate degree OR Masters degree & 3 years of experience in Supply Chain OR Bachelors degree & 5 years of experience in Supply Chain Preferred Qualifications: Strong communication and technical writing skills? Strong ability to work in cross functional teams. Working knowledge and understanding of GMP regulations and GDP requirement. 4+ more years of experience in cold chain logistics, quality, compliance, regulatory affairs, supply chain. Operational Excellence experience or training. Distribution and Transportation knowledge of Latin American Import & export Regulations for Biotech products. Biotech cold chain distribution compliance across Latin America countries. Understanding of Latin America countries infrastructure capabilities to development distribution network for biotech products introduction. Previous interactions with Customs Authorities and Freight Forwarder associations. Experience with local cross functional working groups for developing policies and guidelines across the region. Skills in handling multiple responsibilities, priorities, tasks, and projects simultaneously. Skills in working under time pressure, and effectively in a team matrix environment. Practical project management software and spreadsheet skills, proficient computer operation skills. Effective interactions in a team or matrixes environment. Good organizational skills, detail-oriented & accurate, analytical skills. Team player, self-starter, persistent, tactful, and persuasive.. Effective verbal and written communication skills (writing and presentations). Ability to assume increasing levels of responsibility.. Motivated self-starter who is able to change in an ambiguous environment. Fluent English and Spanish (verbal and written). Good negotiation skills. Problem solver. Proven ability to deliver results GMP, GDP, IATA, DOT and TSA knowledge. Cold Chain and transportation knowledge. Experience with audit processes including CAPA, etc. Experience in managing suppliers and improving processes Understanding logistics processes of parcel, transport and warehousing providers. Strong communication and presentation skills (verbal and written). Able to work autonomously. Able to work under pressure. Able to work in teams. Understanding of warehouse and distribution business processes. Technical Writing. Validation and Qualification Knowledge. Project Management Skills
Job Types: Full-time, Contract
Pay: $30.00 – $34.00 per hour
Schedule:
- 8 hour shift
- Monday to Friday
Experience:
- Transportation Analysts: 5 years (Preferred)
- Lean Six Sigma: 3 years (Preferred)
- Supply Chain & Logistics: 3 years (Preferred)
- Validation Process: 3 years (Preferred)
- Validation Protocols: 3 years (Preferred)
Work Location: One location