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Environmental Monitoring Technicians " I

Company: Zillion Technologies
Location: Durham
Posted on: October 12, 2019

Job Description:

Job Title: Environmental Monitoring Technicians " I Location: Durham, NC Duration: 12 months Qualifications: At least 1-3 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. Responsibilities: Preferable if experienced with EM Lab assays - EM Plates, Nitrates, Conductivity, TOC, LAL, Bioburden, Microbial Water, Growth Promotion, Micro-IDs, pH, Freezing Point, Characteristics, and Specific Gravity. Preferable if experienced with LIMS, Trackwise, SAP. The Contractor Environmental Monitoring Specialist (CEMS) provides direct Technical Services to a production area as part of an IPT (Integrated Production Team) operating model. The CEMS, with guidance from the IPT Technical Services Leadership team, ensures product / process quality and performs activities to facilitate the release of product to the marketplace. The CEMS is responsible for the review and evaluation of routine and per process environmental monitoring (EM) sampling of classified areas, and leads all investigations into environmental excursions. This position also works closely with the assigned end-to-end IPT in a team environment to ensure timely completion of responsibilities, creation of effective corrective/preventative actions, with emphasis on right first time. The CEMS will become knowledgeable in Federal and other regulatory agency requirements and GMPs to assure that all areas operate in a state of compliance, and will train on and gain competency in their responsibilities for assigned IPT. Specific responsibilities include but are not limited to the following: Monitor environmental performance against specifications within classified areas. Provide environmental support to manufacturing and testing areas as needed. Perform investigations into environmental excursions. Actively participates in the Tier process and uses this forum to escalate concerns and best practices. Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans. Adherence to SOPs, GMPs and safety procedures. Author environmental project protocols and reports

Keywords: Zillion Technologies, Durham , Environmental Monitoring Technicians " I, Other , Durham, North Carolina

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