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Quality Auditor - Scientific - I (Assistant)
Ref No.: 18-07451
Location: Durham, North Carolina
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.