Description:Position Summary:Individual will be responsible for completing production batches and corresponding documentation for the associated tasks, AQL inspections, reworks and Material reconciliation that goes along with the batch.Primary Responsibilities:Production:Execute production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPsQuality:Ensure that all batch paperwork is completed in an accurate, thorough, and timely mannerPerform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulationsMaintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirementsOperate cleaning equipment, utilize SOP and documentation to record data manually or through identified software applications.Safety:Comply with all safety policies and procedures at all timesAppropriately use PPE (Personal Protection Equipment)as required to perform routine and non-routine duties.Other Duties:Perform computer applicationsPerform other duties as assigned by ManagementSkills:Certification in a Bioworks Program or equivalent is preferredDemonstrated proficiency in the operation of high speed, highly automated, production equipment preferred.Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred.Knowledge of FDA and/or GMP regulations preferred.Mechanical background preferred.Ability to rapidly learn new procedures and reduce them to practice.Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 75-day period of working with a trainer.Education:High School Diploma or GEDKnowledge and Experience:Minimum of 0-1 years of relevant experience in a regulated production/operations environmentAdditional Information:Performs all job functions and responsibilities in a safe and responsible manner.Excellent personal hygiene required.Reasonable, reliable attendance and punctuality is an essential job function required for this position.Ability to operate motorized pallet jacks or forklift.Ability to remain to stand for long periods of timeLifting, pushing, and pulling may be required for stocking and movement of equipment.May be exposed to Static De-ionizing bars and require individuals with pacemakers to remain 21 inches awayMay be exposed to Chemical Hazards and require the handling of chemicals, antibiotics and/or hazardous materials.May be exposed to strong odors incurred during media production or other operations.Job Duties are performed wearing various types of PPE and cGMP which include but are not limited to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPR, face mask and lab coat.Ability to stand for long periods of timeAbility to lift between 50-100lbsAbility to push/pull up to 150+lbsNotes:Normal working hours for this role are 7:00am - 3:30pm working a Monday thru Friday schedule. VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status
Description:Position Summary:Individual will be responsible for completing production batches and corresponding documentation for the associated tasks, AQL inspections, reworks and Material reconciliation that goes along with the batch.Primary Responsibilities:Production:Execute production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPsQuality:Ensure that all batch paperwork is completed in an accurate, thorough, and timely mannerPerform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulationsMaintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirementsOperate cleaning equipment, utilize SOP and documentation to record data manually or through identified software applications.Safety:Comply with all safety policies and procedures at all timesAppropriately use PPE (Personal Protection Equipment)as required to perform routine and non-routine duties.Other Duties:Perform computer applicationsPerform other duties as assigned by ManagementSkills:Certification in a Bioworks Program or equivalent is preferredDemonstrated proficiency in the operation of high speed, highly automated, production equipment preferred.Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred.Knowledge of FDA and/or GMP regulations preferred.Mechanical background preferred.Ability to rapidly learn new procedures and reduce them to practice.Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 75-day period of working with a trainer.Education:High School Diploma or GEDKnowledge and Experience:Minimum of 0-1 years of relevant experience in a regulated production/operations environmentAdditional Information:Performs all job functions and responsibilities in a safe and responsible manner.Excellent personal hygiene required.Reasonable, reliable attendance and punctuality is an essential job function required for this position.Ability to operate motorized pallet jacks or forklift.Ability to remain to stand for long periods of timeLifting, pushing, and pulling may be required for stocking and movement of equipment.May be exposed to Static De-ionizing bars and require individuals with pacemakers to remain 21 inches awayMay be exposed to Chemical Hazards and require the handling of chemicals, antibiotics and/or hazardous materials.May be exposed to strong odors incurred during media production or other operations.Job Duties are performed wearing various types of PPE and cGMP which include but are not limited to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPR, face mask and lab coat.Ability to stand for long periods of timeAbility to lift between 50-100lbsAbility to push/pull up to 150+lbsNotes:Normal working hours for this role are 7:00am - 3:30pm working a Monday thru Friday schedule.
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