Akorn 2 1st Shift Environmental Monitoring Supervisor - 1192BR in Decatur, Illinois

This job was posted by https://illinoisjoblink.illinois.gov : For more information, please see: https://illinoisjoblink.illinois.gov/ada/r/jobs/6419127 NOTICE: The following includes data on essential functions, as well as physical, mental, academic and experiential requirements for the job defined herein. This description is meant to serve interviewers, applicants, managers and incumbents as a reference tool for determining whether applicant or employee qualifications are sufficient to perform the tasks and assume the responsibilities as described. Some aspects of the job may change over time, according to business needs, which changes may not be recorded herein at this time.n

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nSUMMARY:n

Under the general supervision of the Director of Microbiology, the Environmental Monitoring Supervisor ensures staff is trained, troubleshoots environmental test excursions, develops and implements sampling procedures. This individual ensures testing is conducted in accordance with SOPs and Methods, and ensures department SOPs and training meet Company and FDA standards.

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nESSENTIAL FUNCTIONS:n

Include the following. Other duties may be assigned.

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+ Assures the adherence of Akorn, Inc.’s Environmental Monitoring program by all department staff.

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+ Ensures the monitoring of all parameters defined in Akorn, Inc.’s Environmental Program for Viable, Non-Viable Particulate, Temperature, Differential Pressures (Delta-P), and Humidity of controlled areas.

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+ Coordinates and performs the Gown Certification Program for all personnel that require access to the Aseptic Core or Controlled Testing Area.

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+ Ensures that all documentation associated with an executed batch record (graphs for Differential Pressures, Humidities, Temperatures and Non-Viable Particulate) data are generated, reviewed before the documentation are forward to Microbiology Manager for approval.

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+ Generates and assesses the “Event List” containing critical environmental parameters.

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+ Ensures that all raw data is reviewed before entered in the Database used for tracking and trend analysis. Supply data for various reports when requested.

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+ Determine test sites for all routine and non-routine environmental monitoring performed in controlled areas (Class 100 to Class 100,000).


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+ Ensures that all Media Fill Summary Reports are filled with the appropriate environmental data.

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+ Reviews and approves laboratory test results and documentation and delegates portions of this task to technicians under direct supervision.

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+ Supervised training adequacy, adherence to SOPs and methods based on company and regulation standards.

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+ Performs employees’ performance appraisals in a timely manner.

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+ Assists in the interview process of new personnel (Microbiology and Environmental Monitoring).


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nADDITIONAL RESPONSIBILITIES:n

Other duties that are done on a weekly, monthly, and annual basis:

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+ Maintain Environmental Monitoring Department SOPs.

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+ Ensures that all automated systems (hardware and software) are properly qualify and maintained.

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+ Provide training.

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+ Ensures that the roster of gown certify personnel is accurate based on certification standards.


nSupervisory - Directly supervises employees in the Environmental Monitoring Department. Supervises environmental monitoring program in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing and training employees, planning, assigning, and directing work, appraising in performance, rewarding and disciplining employees, and addressing complaints and resolving problems.n

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nQualificationsn

QUALIFICATIONS:n

To perform this job successfully, an individual must be able to pe form each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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nEDUCATION AND EXPERIENCE:n

Bachelors' Degree in Biology Science, Associates' Degree, or equivalent from two-year college; or minimum of five years experience in an environmental or microbiology laboratory and/or training; or equivalent combination of education and experience. Also need experience with cleanrooms.

Certificates, Licenses, Registrations: Gowning Certification given by the Company.

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nJOB PREREQUISITES:n

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+ Ability to meet attendance standards. All full - time employees are required to work a 40 hours week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.

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+ This individual must have an understanding of the regulatory guidelines and/or compliance documents.


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nPHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT:n

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Requires sitting, standing, bending, and reaching. May require lifting up to 30 pounds. Requires manual dexterity sufficient to operate standard office machines such as computers, fax machines, calculators, the telephone, and other office equipment. Requires normal range of