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Batch Record Auditor

Company: Abbott Laboratories
Location: Auburn
Posted on: September 24, 2022

Job Description:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries. MAIN PURPOSE OF ROLE Summarize the main purpose of the role. This role audits the accuracy of batch records to be compliant with policies, procedures, and regulatory requirements. This position ensures all necessary documents are included within the batch record, maintains databases and batch record files so that retrieval for historical data is accurate and timely. Batch records are required to be in compliance with federal regulations pertaining to Low Acid Canned Foods, Infant Formula Quality Control, and Good Manufacturing Practices. Assure compliance to Federal Regulations pertaining to Low Acid Canned Foods, Infant Formula Quality Control, Acidified Foods, Bottled Water Regulations, Nutritional Labeling Laws, and Good Manufacturing Practices. MAIN RESPONSIBILITIES Review work orders for completeness and compliance to all Abbott policies, procedures, requirements, and government regulations.Elevate batch record quality issues to Quality Systems management for disposition.Follow up on all work order issues to ensure each is investigated prior to Production supervision or Quality Assurance specialist reviewIdentify and communicate with operations personnel and management any issues or discrepancies within work ordersTrain new employees when neededPrioritize batch review when needed for customer demandProvides support for batch record related data collection Education Level High School Diploma / GED Experience Experience Details Minimum 1 yearexperience computer entry skills

Keywords: Abbott Laboratories, Fort Wayne , Batch Record Auditor, Accounting, Auditing , Auburn, Indiana

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