Independently performs the tasks of the production operation specific to Environmental Monitoring for aseptic manufacturing and filling. Maintains batch record, documentation and logs as required by corporation and regulatory agencies. Performs cleaning and sanitizing of production equipment and classified production space. Prepares plates as required by the production process. Prepares equipment, glassware, filters, etc. required for production. Assists in process manufacturing activities as required. Independently performs product sampling, environmental monitoring, or other related activities as directed.
The candidate will perform environmental monitoring of aseptic manufacturing operations in Grade A, B and D clean room environments and other classified areas as required. Additional responsibilities will also include environmental monitoring sample release, paperwork, data review and data input into a computerized database. Additional duties will include review of environmental monitoring standard operating procedures.
Perform routine Environmental monitoring of Aseptic manufacturing areas.
Will serve as witness of routine unit operation tasks for batch record signing. Maintains all associated documentation for operations being performed. Applies acquired skills while performing the most complex tasks of the position, following established practices and procedures. Demonstrated ability to apply experience to perform equipment troubleshooting as needed. Implements and maintains production schedules based upon intra-departmental information. Perform to ensure compliance with GMPs and SOPs.
Ability to accommodate production requirements that may require 50+ hour work weeks, including extended day hours and weekend. Core Work hours are 2:00PM to 10:30PM. This role requires frequent work on weekends depending on production demands.
Prior Environmental Monitoring experience and experience working as an Aseptic Production operator is required.
Excellent written and verbal communication skills
Knowledge of computer and software application such as Excel and Word
Typical minimum education and experience required is AA degree in related discipline and experience working in Aseptic areas is required. Or High School diploma with minimum 3+ years of experience working in Aseptic areas.
Source: Job Diva – Job Listing