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Environmental Monitoring Technicians: Pharmaceutical Manufacturing
Ref No.: 18-03600
Location: Durham, North Carolina
Position Type:Contract
Job Category:Biotech/Pharmaceutical
Benefits:Dental Insurance, Medical Insurance
*1 year contract position with opportunity for extension or hire based upon performance and business need*

The company: 
Our client is a global healthcare company. The Company offers health solutions through its prescription medicines, vaccines, biologic therapies and animal health products. It operates through four segments: Pharmaceutical, Animal Health, Healthcare Services and Alliances. The Company's Pharmaceutical segment includes human health pharmaceutical and vaccine products marketed either directly by the Company or through joint ventures. Human health pharmaceutical products consist of therapeutic and preventive agents, generally sold by prescription, for the treatment of human disorders. The Company sells its human health pharmaceutical products primarily to drug wholesalers and retailers, hospitals, government agencies and managed healthcare providers, such as health maintenance organizations, pharmacy benefit managers and other institutions. Vaccine products consist of preventive pediatric, adolescent and adult vaccines, primarily administered at physician offices.

At least 1+ years of relevant post-degree work experience in Environmental Monitoring, Aseptic Manufacturing or Microbiological Laboratory Operations. Evidence of good oral and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills. Attention to detail, flexibility and an awareness of production and attendant quality control problems. Basic understanding of GMPs and of regulatory requirements as they apply to the vaccine, sterile pharmaceutical or related fields. Ability to sit, stand and move within work space for extended periods, ability to perform repetitive tasks including frequent hand to finger manipulations, grasping pushing and pulling; ability to lift up to 50 pounds. The candidate must pass a varicella titer prior to arriving for first day on job.

Qualifications Preferred: Quality Control, Quality Assurance and/or cGMP experience. 

Specific to Environmental and Utility Monitoring, the Analyst will be responsible for maintaining the EM program to include the following:
- Collection and testing of qualified Utility systems including Clean Steam, WFI and compressed gases. - Execute environmental sampling of Classified Areas including active air sampling, surface sampling and non-viable air sampling. - Provide data entry, review and approval as required. - Provide summaries of test results to appropriate personnel as needed. - Compile and evaluate environmental data for adverse trends. - Directly support Performance Qualification activities. - Perform routine monitoring of Personnel. - Compile and author Annual Reviews. - Author and summarize Requalification, Performance Qualification, and Special Study protocols. - Perform monthly and weekly sample accountability. - Submit LIMS sample rejections. - Equipment Calibration and Management - Filing data sheets and document control of logbooks - Other duties requested by Management. 

Pay Rate: $30 - $34 per hour 
Drug and background screenings required