Description:Position Summary:Responsible for verification of materials and products as directed by procedures and or batch record requirements. Responsible for labeling, inspecting, and production of final container products with manual and/or automated systems. Also responsible for set-up, changeover and operation of labeling and production equipment. Responsible for data entry and computer generated labels. Maintains records and production area to comply with regulatory requirements, good manufacturing practices, and standard operating procedures. Performs reconciliation activities and determines compliance to specification, floats on all lines. Assists in investigation of non-conforming results. Performs final production check of completed documents for completeness and accuracy. Key Responsibilities:Review of completed batch records for compliance with cGMPs, validation, and standard operating procedure requirements. Reconcile labeling and product components and determine compliance with specifications. Assist in investigation of non-confirming results related to either reconciliation or production activities. Maintenance of logs, batch records, and all applicable documentation in accordance with cGMP specifications and internal standard operating procedures. Maintain qualification to clean and verify thermoforming equipment, perform on-line product inspections, off-line inspections, and leak testing in accordance with qualification requirements. Ability to perform at or above established quality and productivity standards on all lines. Perform additional duties as assigned by management. Regular attendance is an essential function of the job. Follow all applicable government regulations including HIPAA, FDA, OSHA, and EPA. Display behavior which exemplifies employee code of conduct guidelines and Client Core Values. Physical Demands:May sit, stand, stoop, bend and walk intermittently during the day. May sit or stand seven (7) to ten (10) hours per day. May be necessary to work extended hours as needed. Finger dexterity to operate office equipment required. May need to lift up to twenty-five (25) pounds on occasion. Visual acuity to see and read fine prints. Specific vision abilities required by this role include close vision, color vision and the ability to adjust focus. Must be able to hear normal voice sounds. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this role. Work Environment:Work in a climate-controlled, smoke-free internal environment. ExperiencePrevious Production experience is preferredComputer skills and data entry experience.An Ideal candidate would have had previous Assembly experience EducationHigh School graduate (or equivalent) Notes:Mon-Thurs 6-430.Must be able to work Friday OT 6-430 as needed.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:
Responsible for verification of materials and products as directed by procedures and or batch record requirements. Responsible for labeling, inspecting, and production of final container products with manual and/or automated systems. Also responsible for set-up, changeover and operation of labeling and production equipment. Responsible for data entry and computer generated labels. Maintains records and production area to comply with regulatory requirements, good manufacturing practices, and standard operating procedures. Performs reconciliation activities and determines compliance to specification, floats on all lines. Assists in investigation of non-conforming results. Performs final production check of completed documents for completeness and accuracy.
Key Responsibilities:
Review of completed batch records for compliance with cGMPs, validation, and standard operating procedure requirements. Reconcile labeling and product components and determine compliance with specifications. Assist in investigation of non-confirming results related to either reconciliation or production activities. Maintenance of logs, batch records, and all applicable documentation in accordance with cGMP specifications and internal standard operating procedures. Maintain qualification to clean and verify thermoforming equipment, perform on-line product inspections, off-line inspections, and leak testing in accordance with qualification requirements. Ability to perform at or above established quality and productivity standards on all lines. Perform additional duties as assigned by management. Regular attendance is an essential function of the job. Follow all applicable government regulations including HIPAA, FDA, OSHA, and EPA. Display behavior which exemplifies employee code of conduct guidelines and Client Core Values.
Physical Demands:
May sit, stand, stoop, bend and walk intermittently during the day. May sit or stand seven (7) to ten (10) hours per day. May be necessary to work extended hours as needed. Finger dexterity to operate office equipment required. May need to lift up to twenty-five (25) pounds on occasion. Visual acuity to see and read fine prints. Specific vision abilities required by this role include close vision, color vision and the ability to adjust focus. Must be able to hear normal voice sounds. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this role.
Work Environment:
Work in a climate-controlled, smoke-free internal environment.
Experience
Previous Production experience is preferred
Computer skills and data entry experience.
An Ideal candidate would have had previous Assembly experience
Education
High School graduate (or equivalent)
Notes:
Mon-Thurs 6-430.
Must be able to work Friday OT 6-430 as needed.
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