Preparation Operator (3rd Shift)
927 S Curry Pike Bloomington, IN 47402 Bloomington, IN 47402 US
Job Description
Target Pay Rate: 18.70/hr **salary will be commensurate with experienceÂ
Job Description:Â
The Prep Operator (Operator II) will work in and maintain a Grade C/D environment. They will perform routine cleaning and sanitization to help ensure readiness and current Good Manufacturing Practices (cGMP) compliance within the classified and non-classified work areas. Activities shall include cGMP compliant gowning, conformance to Good Documentation Practices (GDP) standards, integrity testing of filters, and cleaning, setup, and sterilization of equipment and components. Ability to operate preparation equipment such as autoclaves, sonicators, depyrogenation ovens, and vial and stopper washers. The Preparation Operator may be required to cross-train as a support Operator for additional areas. This position reports to the Manufacturing Supervisor.Â
Essential Duties and Responsibilities:Â
- Understand and follow current Good Manufacturing PracticesÂ
- Perform routine cleanup and sanitizations as assigned by area supervision to maintain cGMP compliance within the Grade C/D work areasÂ
- Perform sanitizations in a timely and effective manner in accordance with cGMPs and client procedures, maintaining production scheduleÂ
- Maintain organization at all times within the classified areas to ensure segregation, readiness and to prevent any contamination or rejection of batchesÂ
- Compare Lot numbers to ensure correct components are being used for the specified batchÂ
- Complete calculations to support preparation activitiesÂ
- Retrieve and test in-process samplesÂ
- Clean and sample equipmentÂ
- Required to maintain attendance in accordance with the Bloomington Attendance PolicyÂ
- Scheduled weekend overtime will be requiredÂ
Work Environment:  Classified pharmaceutical environment including wearing required gowning as shown in attached document.  Occasional work with water and pharmaceutical product while wearing applicable Personal Protective Equipment.  Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.Â
Qualification Requirements: To perform this job successfully an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals to perform the essential functions:Â
- Ability to work independentlyÂ
- Good communication skillsÂ
- Good documentation skills, including legible handwritingÂ
- Good interpersonal skillsÂ
- Basic computer skills, including ability to navigate enterprise software (ie Pilgrim, JDE, etc)Â
- Basic math skillsÂ
- Knowledge of aseptic manufacturing practicesÂ
- Knowledge of standard operating procedures, specifications, and job-specific training materialsÂ
- Requires the operation of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices.  Ability to demonstrate proficiency in reading equipment drawings.  Ability to work safely with equipment under pressure.Â
Education and Experience:  High school diploma or GED required, 6 months of previous Pharmaceutical or Manufacturing experience preferred.Â
Language Skills: Must be able to understand, speak, read and write English in order to comply with necessary SOP’, job-specific training materials, GMP’s, and other manuals.Â
Physical DemandsÂ
- Occasional (0-33%) Sitting, climbing stairs and ladders, overhead reaching and/or lifting, balancing, kneeling, crouching, crawling, operating controls
- Lifting and carrying up to 53 lbs
- Pushing up to 105 lbsÂ
- Pulling up to 22 lbs
- Frequent (34-66%) Standing, walking, reaching forward, stooping, object handling, fingering, fine hand coordination simple and firm hand grasping Â
- Lifting and carrying up to 34.25 lbs
- Pushing and pulling up to 15 lbsÂ
Additional Requirement:  Final candidates for Prep Operator will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.Â
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