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Pharmaceutical Production Quality Auditor
Ref No.: 18-02644
Location: Durham, North Carolina
Position Type:Contract
Job Category:Biotech/Pharmaceutical
Benefits:Dental Insurance, Medical Insurance
*1 year contract position, with additional opportunity based upon performance and continued business need*

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. 

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 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

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

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

Pay Rate: $18.50 per hour
Drug and background screenings required

On-Board Services provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.