Environmental Monitoring Manager

Cognate BioServices in Memphis, TN

  • Type: Full Time
position filled
POSITION SUMMARY: Reporting to the Director, the Environmental Monitoring Manager will manage the environmental monitoring program at Cognate Memphis. As such will be responsible for collecting information, organizing the processes and authoring SOPs, Protocols and Reports. Interactions will be extensive within the company and extend to other external clients and collaboration partners.  The EM Manager is expected to well with QC-Microbiology and site Manufacturing personnel. The incumbent will be expected to lead and role model a commitment to the environmental quality of the plant. ESSENTIAL DUTIES AND RESPONSIBILITIES: Ensure that all cGMP’s are followed at all times. Provide Day-to-day, ongoing microbiology & sterility assurance expertise and practical support to the Cognate Quality and Manufacturing teams Responsible to review and investigate all Environmental Monitoring excursions in compliance with USP 1116, EU Annex 1 and 21 CFR 211 requirements Provide support to Quality Assurance team for the trend of atypical cycles and implement corrective action. Review impact of product, equipment, process change to sterilizer qualification status. Provide inputs and approve change controls affecting sterilization process. Review and assess the Change Controls in relation equipment or systems that would impact the bioburden and sterility of product. Provide effective management of projects impacting sterility assurance and related utilities to ensure that all work meets standards and other requirements. Ensuring compliance to the Cognate Quality Management System related to Sterility Assurance Perform environmental testing during the processing of Intermediate and Finished Product. Maintain laboratory and facility in a clean and orderly fashion as 5S requirement. Update and prepare standard operating procedure as related to Sterility Assurance and Microbiological testing. Adhere to Corporate quality procedures, Plant procedures, current Good Manufacturing Practices and safety standards at all times to maintain high scientific quality. EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS: Bachelor degree in Microbiology, Biotechnology or related science Minimum 5 years experiences in microbiological laboratory in a pharmaceutical manufacturing environment Possess knowledge in GMP, ISO 9001, sterility testing, method validation and GLP in a pharmaceutical manufacturing environment will be an advantage Research and analytical skills for investigating issues and analyzing trends Ability to perform detailed-oriented work with a high degree of accuracy. Ability to explain complex concept with clarity and simplicity. Must possess effective organizational and time management skills with the ability to multitask and work towards multiple priorities and goals. Should understand and be able to apply communication theory and practices to designing, creating, editing and revising documentation. Must be able to work independently but be able to identify problems proactively and know when to seek advice. Must be able to work under tight deadlines while delivering a high quality output.

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