| The VMF IPT Sample Coordinator is responsible for product sample delivery and document coordination that supports VMF101/102production; he/she must adhere to regulatory, global and site policies and procedures governing product release. GENERAL EXPERTISE ? Requires knowledge and experience in own discipline; still acquiring higher-level knowledge and skills ? Builds knowledge of the company, processes and clients and/or customers ? Solves a range of straightforward problems ? Analyzes possible solutions using standard procedures ? Receives a moderate level of guidance and direction ? Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals BUSINESS EXPERTISE: ? Understands the fundamental business drivers for the company; uses this knowledge in own work ? Understands and applies regulatory/ compliance requirements relative to their role FUNCTIONAL EXPERTISE: ? Basic conceptual knowledge and practices associated with Document Review and Product Disposition ? Essential Functions: ? Responsible for the generation and review of sample lab documentation/labels associated with media/filled vials ? Review/inspection/delivery of samples; attention to detail/accuracy are critical ? Coordinate shipping documentation and sample preparation for domestic and international shipments to applicable health authorities and intra-sites ? Execute review of electronic Master Batch Records (eMBR's) of critical steps and parameters as applicable ? Work with Operations Technical Support Team and Coaches to resolve issues identified during document review ? Other duties: ? Participate in process improvement or learning events, as guided or approved by Operations management ? Direct support of project activities and all other associated Operations functions ? Other duties as requested by Management PROBLEM SOLVING: ? Identifies and solves a range of problems in straightforward situations; analyzes possible solutions and assesses each using standard procedures INTERNAL CLIENT/EXTERNAL CUSTOMER FOCUS: ? Responds to standard requests from clients and/or customers IMPACT: ? Errors or lack of understanding of the job may cause delays in releasing material for use in Operations and to the end market ? Influence and Decision Making: ? Explains information and persuades others in straightforward situations ? Makes decisions within guidelines and policies that impact own priorities and allocation of time to meet deadlines PROJECT MANAGEMENT: ? Accountable for quality contribution to project team or sub-team RESOURCE MANAGEMENT: ? Aware of costs and assists in controlling costs related to own work PHYSICAL REQUIREMENTS: ? Ability to sit, stand and move within work space for extended periods ? Ability to perform repetitive tasks ? Ability to lift up to 40 pounds ? Ability to tolerate working in cold storage (-20�C) for short durations several times a day/week WORKING RELATIONSHIPS: Reports to Associate Director, VMF Operations Manufacturing Support. Interacts with employees within own department. Frequent interaction with employees from other departments Interacts with representatives from regulatory agencies Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned|
Associate's Degree in Biology, Biochemistry, Chemistry or equivalent years of experience in discipline field Preferred: Operations, Quality Control, Quality Assurance and/or cGMP experience. Effective communications (oral/written) and interpersonal skills are necessary.