Batch Records Auditor- Columbus Plant- 1st shift

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 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

The Batch Record Auditor is responsible for auditing and assuring accuracy of production records. It is the responsibility of the auditor to 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. Further, this individual 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.

Main Responsibilities

Reviews work orders for completeness and compliance to all Ross policies, procedures, IOP requirements and Government regulations.

Initiates NCMR’s, SQE’s and PIR’s and route to Sr.

Batch Auditor or Supervisor for disposition.

Follows up on all issues to assure each is addressed and completed prior to submission of work order to supervisor.

Enters and maintains work orders, NCMR’s, SQE's, Discrepancies and Alert levels into the RBA system.

Ensures holds and isolation have been initiated as required.

Works with appropriate personnel for sampling plans, initiate sample requests, write inspection and reworks.

Uses CAMBAR and Amaps to adjust or obtain release status for specific batches.

Audits and maintains records for non-batch log related items (i.e.: Tank Temps, CIP charts) Identifies and communicates with manufacturing personnel and management any issues or discrepancies that may require workorder changes.

Trains new employees where needed.

Completes COA’s for Abbott Intl. and DQA.

Provides support for data collection. i.e.: PQA lab, Engineering and DQA Expedites batch review when asked by Division to meet consumers demands.

This position will work under the direction of the Quality Systems Supervisor or Manager.

The Auditor is responsible for the complete audit of the work orders in Quality Systems.

This position is independent and a final batch review is completed by Sr Batch Auditor on only a few critical items.

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.

Bachelors’ degree in a technical field preferred.   A thorough knowledge of the manufacturing process including Analytical Processing, and Filling is required. Proficiency in computer applications strongly desired, certification in Low Acid Food processes required. Must have the ability to analyze and trouble shoot existing/potential problems, have strong communication and writing skills and the ability to prioritize workload to meet batch release timing.

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