Sr. Batch Records Auditor

ABOUT ABBOTT

Abbott is a global healthcare leader creating breakthrough science to improve peoples health. Were always looking towards the future anticipating changes in medical science and technology.

WORKING AT ABBOTT

At Abbott you can do work that matters grow and learn care for yourself and your family be your true self and live a full life. Youll also have access to:

• Production areas that are clean well-lit and temperature-controlled

• Training and career development with onboarding programs for new employees and tuition assistance

• Financial security through competitive compensation incentives and retirement plans

• Health care and well-being programs including 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 and FreeU education benefit - an affordable and convenient path to getting a bachelors degree.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

• A stablecompany with a record of strong financial performance and history of being actively involved in local communities

• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity working mothers female executives and scientists.

OVERVIEW

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.

WHAT YOULL DO

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

• Initiates NCMRs SQEs and PIRs 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 NCMRs SQEs 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 withmanufacturing personnel and management any issues or discrepancies that may require workorder changes.

• Trains new employees where needed.

• Completes COAs 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.

REQUIRED QUALIFICATIONS

• 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. Pre-Employment Inquiries and Citizenship U.S. Equal Employment Opportunity Commission ()

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:

*Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer and a Military/Veteran friendly Employer committed to employee diversity.

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The base pay for this position is

In specific locations the pay range may vary from the range posted.

Senior IC