Senior Batch Record Auditor

Abbott•Columbus, OH

3d•Onsite

About The Position

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.

Requirements

HSD/GED required; 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.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

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 work order 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.

Benefits

Training and career development
onboarding programs for new employees
tuition assistance
competitive compensation
incentives
retirement plans
medical, dental, vision, wellness and occupational health programs
Medical Benefits start day 1
Vacation – 120 hours of accrued vacation (1st yr is prorated) + vacation buy program + 5 personal days + 10 paid holidays
Retiree Healthcare program
Robust 401(k) retirement savings with a generous company match
Tuition reimbursement
the Freedom 2 Save student debt program
FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.