Formulation & Preparation Operator

Summary:

TheFormulation & PreparationOperator (Operator II& III)positionsupports aseptic filling operations bystaging and delivering components conducting in-process testingweighing materials formulation of product and conducting in-process testingfiltrationcleaning and sanitization sterilization ofequipmentbatch reconciliationcompliant gowning setup and operation ofparts washer autoclavesand tank cleaningin conformance with current Good Manufacturing Practices and Good Documentation Practices (cGMP/GDP) standards.The Operator will alsoinitiateminor revisions to existing documents and troubleshoot simple processes / equipment failures. The Operator maybe requiredto cross-train as a support Operator foradditionalareas. This positionreportsto the Manufacturing Supervisor.

EssentialDutiesandResponsibilities(theseareprimaryresponsibilitiesoftheroleandtheincumbent will perform other duties as assigned):

• Understand and follow current Good Manufacturing Practices(GMP)

• Understand and follow current GoodDocumentationPractices(GDP)

• Perform routine cleanup line clearancesandsanitizations asassigned by area supervision tomaintaincGMP compliance within theCleanroomwork sanitizations ina timelyand effective mannerin accordance withcGMPsandSimtraproceduresmaintainingproduction schedule.

• May berequiredto cross train as a support operator toassistadditionalmanufacturing areas.

• Maintain organization at all timeswithin the classified areas to ensure equipment segregation readiness and to prevent any contamination or rejection of batches.

• Perform routine verification of equipmentand instruments.

• Compare Lot numbers to ensure correct components are being used for the specified batch

• Complete calculations to support preparationand formulationactivities

• Retrieveand test in-process samples

• Clean Sterilizeand sample equipment

• Setupand operateautocalves parts washerstank cleaning and formulation stationsinCleanroomareas.

• Assistin the training and development of other team members

• Required tomaintainattendancein accordance withthe Bloomington Attendance Policy

• Scheduled weekend overtimemayberequired

JobRequirements(EducationExperienceandQualifications):

• High school diploma or GEDrequired 6 months ofpreviousPharmaceutical or Manufacturing experience preferred.

• Must be able to understand speakreadand write Englishin order tocomply withnecessary SOPs job-specific training materials GMPs and other manuals.

• Basic Computer skillsinMicrosoftWordExcelandOutlookandtheabilitytouseenterprisesoftware(examples include:Veeva D365 Blue Mountain etc.)

• Musthavetheabilitytoworkeffectivelyinahandsonenvironmentcapableoftroubleshootingcomplex equipmentandsystems

• Competency inoperation of multiple types of equipment related tothe manufacturingoperations as well as hand operated equipment including but not limited to such things as calipers scales gauges and other measuring todemonstrateproficiencyin reading equipment to work safely with equipment under pressure.

Physical/SafetyRequirements

• Mustbe abletoliftand carryupto70lbs andpush and pullup to150 lbs.

• Extendedperiodsofstandingand/orwalking

• ExtendedperiodsinGradeABCDproductionenvironments

• Useofhandsandfingerstomanipulateequipmentisrequired