Previous Job
Previous
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

Quals--
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.