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Environmental Monitoring Coordinator

Company: Renaissance Pharmaceuticals
Location: Lakewood
Posted on: September 1, 2019

Job Description:

Overview

This position is primarily responsible for carrying out programs for environmental monitoring of controlled manufacturing environments as per regulated microbial and non-viable parameters.

Responsibilities

  • Exemplify Renaissance Core Values
    • Performs job functions in conformance to current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP) specifically associated with assigned tasks and generally as a Renaissance employee.
      • Maintains qualifications/proficiency through continual training and monitoring.
        • Regularly work within the controlled areas (classified)
          • Properly gown in conformance to the approved gowning procedures associated with the classification being entered.
          • Exhibit good aseptic technique while observing an assigned controlled area.
          • Performs scheduling of environmental monitoring for controlled environments per frequency requirements and production schedule.
          • Maintain complete and accurate documentation of assigned job functions in accordance to Good Documentation Practices (GDP).
          • Keeps manufacturing, engineering, and quality management advised as to program status, alert and action conditions or any trends being observed.
          • Monitor aseptic technique of personnel regularly and report any abnormalities observed to area and/or quality supervision.
          • Represents Microbiology as the process owner.
            • Reports any observation made that can potentially harm the product or process.
            • Provides guidance to those observed not following procedures.
            • Reports any safety concerns to area supervision and/or EH&S.
            • Share operational knowledge with peers, new-hires, temporary staff members, as needed, to maintain efficiencies and cGMP compliance.
            • Participate in team efforts to improve our work environment, product quality, efficiencies, and other initiatives identified as being beneficial to our business.
            • Leads in the development of corrective action programs, improvements, and modifications to environmental monitoring programs as required.
            • Performs observation of processes within controlled areas to ensure control is maintained and proper environmental monitoring takes place in these critical areas.
            • Reconciles samples throughout the shift on a visual basis during dynamic operations and also when samples are delivered to the Microbiology Lab to ensure proper sampling occurred.
            • Coordinates assigned tasks with team members as directed by reporting supervisor.
            • Ability to assist with deviation writing or deviation review as applicable for environmental monitoring excursions.

              Qualifications

              • Requires at least a BS/MS in a scientific discipline.
              • A minimum of 2 years of industry experience, Microbiology preferred.
              • Experience in pharmaceutical or medical device industry where controlled environments were utilized is preferred.
                • Proficient in use of personal computer (MS Word, Excel, Windows, etc.).
                • Possesses good communication and interpersonal skills
                  Education:

                  SAMPLE JD TEXT: Bachelor's Degree in related field required with a minimum of ## years of relevant experience in the pharmaceutical industry or equivalent combination of education and experience. Master's Degree preferred.

                  Required

                  Preferred

                  Education Level

                  High school diploma/ GED

                  One year certificate from college/technical school

                  Two years college education/technical school

                  Bachelor's degree

                  Fifth year college or university program certificate

                  Master's degree

                  Doctoral degree PI113275542

Keywords: Renaissance Pharmaceuticals, Lakewood , Environmental Monitoring Coordinator, Other , Lakewood, New Jersey

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