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.
â-- Responsible for auditing and assuring accuracy of production records. Verify presence of all necessary documents within each production record file and provide feedback to the responsible department when there are discrepancies, errors, or omissions. â-- Maintains databases and files to assure retrieval is accurate and timely when information or metrics are requested. Production records are to be compliant with plant procedures and good manufacturing practices. â-- Reviews work orders for completeness and compliance to all policies, procedures, IOP requirements and Government regulations. â-- Follows up on all issues to assure each is addressed and completed prior to submission of work order to supervisor. â-- â-- Enters and maintains work orders, Discrepancies and Alert levels into the auditing system. â-- Ensures holds and isolation have been initiated as required. Works with appropriate personnel for batch sampling plans, initiate sample requests, write inspection and reworks. â-- â-- Audits and maintains records for non-batch log related items (i.e.: Tank Temps, CIP charts) â-- Provides support for data collection. Errors can result in FDA observations, Corporate Compliance Audit observation, OSHA, Recall or other regulatory action. This position is accountable for complying with applicable FDA (GMP), USDA, OSHA and Abbott/Ross regulations, policies, procedures or guidelines.
","industry":"Healthcare","title":"Batch Record AuditorDivision: ANSC Nutrition Supply Chain
Travel: No
Medical Surveillance: No
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)