Position Summary: Responsible for all production specific activities to the Finishing work areas while working under current GMPs. Controls and maintains area specific inventories using Oracle Inventory System and POMSnet Manufacturing Execution System (MES).

Essential Job Functions:

• Assures that all operations are performed according to SOPs and procedures and reports any deviations from these procedures to Supervisor
• Ability to complete successful gowning qualifications; adheres to proper aseptic gowning and filling techniques
• Fills, caps and labels products while performing visual inspections in accordance with Device Master Records
• Operates within MasterControl
• Operates within POMSnet MES
• Navigates production schedule via the production plan or Smartsheet with assistance
• Operates within Microsoft Teams
• Assures correct and legible identification is applied to the bulk product, filled bottles, labeled bottles, accountability boxes, paper/electronic batch records and other documents
• Performs and documents line clearances at the beginning and completion of each operation
• Completes all POMSnet processes, batch records, attachments and logs accurately while working under current GMPs
• Performs physical counts of filled material accurately; reports any discrepancies immediately to management
• Completes start up activities associated with production runs without assistance
• Generates and confirms correctness of labels for bulk material, accountability boxes, labeled bottles and batch records
• Generates and confirms accuracy of labels from POMSnet
• Performs required tasks as an Outside Technician during the execution of Filling processes accurately without assistance
• Troubleshoots filling units with assistance
• Executes filling processes in the aseptic filling areas as a qualified assistant or operator; operates filling machines for reagents, calibrators, controls and other liquid fills with assistance
• Completes process verifications with assistance as needed
• Maintains all working areas in a clean and orderly state; assures that products are stored in the correct location, segregated, and clearly labeled
• Maintains and monitors aseptic conditions of filling rooms through daily and weekly room cleanings
• Maintains GMP compliance
• Confirms all POMSnet processes, batch records, SOPs and specs are up-to-date and reflect the current procedure
• Participates in the identification of needed revisions of SOPs and Batch Records in accordance with Fujirebio policies and applicable GMPs
• Participates in the identification of departmental process improvements
• Assures that all operations are performed according to SOPs and reports immediately any deviations from procedures to Supervisor
• Assures the proper use of all applicable POMSnet processes, batch records, SOPs and specifications
• Updates the production schedule via the production plan or Smartsheet with the daily production activities as assigned
• Identifies the component inventory needed to execute daily activities and reports low inventory promptly to the technicians designated to order component inventory
• Identifies the supplies needed to execute daily activities and reports low inventories promptly to the technicians designated to order those supplies
• Confirms all components and supplies are within expiration prior to use
• Segregates, accounts for and disposes of damaged, rejected or residual components according to SOPs
• Assists in the execution of and completion of documentation for reworks as assigned
• Performs balance verifications as assigned; reports out of tolerance results immediately to management
• Reports defects and product complaints (both internal and external) promptly to management
• Identifies quality problems and reports them promptly to management
• Assures that all equipment is safe and all safety procedures are followed
• Assures that all equipment is properly maintained, calibrated and validated prior to use
• Completes assigned tasks in a prompt manner both individually or when assigned with a group
• Produces quality work
• Adapts to schedule changes
• Works successfully within a team
• Aides in other operations as assigned
• Follows all company environmental, health and safety policies, procedures and guidelines, and conducts work in a safe manner
• Performs other duties as assigned

Job Specifications (skills, knowledge, special training, certification, license requirements):

• Familiarity with machines/equipment and software
• Daily use of balances, peristaltic pumps, manual and automated liquid filling apparatus and other standard manufacturing equipment
• Use of computer for creation of labels
• Use of computer for the navigation and operation of various software platforms such as QDI, MasterControl, Microsoft Teams, POMSnet and Oracle
• Must be able to operate and enter data into a personal computer or calculator
• Requires the safe operation of Filling department equipment
• Must be able to consistently maneuver products through machinery and manually fill vials
• Must concentrate and focus specifically on the work at hand – safety is first and foremost
• Good communication and interpersonal skills required – teamwork skills essential
• Required to perform visual inspections of equipment and product
• Ability to lift up to 30 lbs.
• Willingness to work with human and animal serum
• Must be able to work in an aseptic filling area which includes gowning and working in the controlled areas for extended periods of time
• Must be able to operate and enter data into a personal computer
• Excellent attendance; ability to work overtime and occasional weekends required

Education and Work Experience Required:

• High school diploma or equivalent required; BS in Life Sciences preferred
• Previous experience in the diagnostics/pharmaceutical industry with knowledge of lab equipment (balances, pH meters, etc.) and knowledge of GMPs, SOPs and batch records desirable

We offer a competitive benefits package that starts on day one, including employer-paid dental & vision, 401(k) match up to 5%, and generous PTO and holiday benefits.

We regret we are not able to respond to each resume received. Only those selected for an interview will be contacted.

Fujirebio Diagnostics is an Equal Employment Opportunity Employer