Abbott Batch Records Auditor - Casa Grande, AZ Plant (1st Shift) in Casa Grande, Arizona

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.

JOB DESCRIPTION:

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.

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. Batch Records Auditors are expected to review their work for errors and correct them before submitting to the Supervisor for review. Errors can result in FDA observations, corporate compliance audit observation, recall or other regulatory action.

Primary Function/ Primary Goals/Objectives:

  • Audit and assure accuracy of batch records to be compliant with policies, procedures and regulatory requirements

  • Ensure all necessary documents are included within the batch record

  • Maintain databases and batch record files to assure retrieval is accurate and timely

  • Assure compliance to Federal Regulations pertaining to Low Acid Canned Foods, Infant Formula Quality Control, Acidified Foods, Nutritional Labeling Laws and Good Manufacturing Practices

Major Responsibilities:

  • Responsible for implementing and maintaining the effectiveness of the quality system

  • Review work orders for completeness and compliance to all AN policies, procedures, Deviation requirements and Government regulations

  • Review SQE’s and PIR’s and route to Sr. Batch Auditor or Supervisor for disposition

  • Follow up on all issues, to assure each is researched prior to submission of work order to Supervisor or Senior Batch Records Auditor

  • Enter and maintain work orders, SQE’s, Discrepancies and Alert levels into the appropriate system

  • Ensure holds and isolations have been initiated as required

  • Works with appropriate personnel for sampling plans, initiate sample requests, write inspection and reworks when necessary

  • Use of CAMBAR and AMAPs to manage batch releases and product holds

  • Audit and maintain records for non-batch log related items (e.g. Tank Chart, Batch records, CIP charts)

  • Identify and communicate with manufacturing personnel and management any issues or discrepancies that impact batch release

  • Responsible to generate and maintain department metrics

  • Complete COA’s for Abbott Intl. and DQA

  • On occasion, may provide administrative support to PQA manager and staff, including but not limited to: data input, tracking and trending QA data, stats, test results, SQE, etc.

  • Develop presentations for QA staff

Education:

Bachelors’ degree in a technical field preferred. High school diploma or equivalent required.

Background:

  • Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals

  • Some knowledge of the manufacturing process including analytical processing and filling preferred

  • Proficient in computer applications

  • Ability to analyze and trouble shoot

  • Must have strong communication and writing skills

  • Ability to prioritize workload to meet batch release timing

  • Certification of Low Acid Food processes (course requirements)

  • Manage Samples for IFA, Commercial Stability, etc.

  • Set up meetings and maintain office supplies

JOB FAMILY:

Operations Quality

DIVISION:

ANSC Nutrition Supply Chain

LOCATION:

United States > Casa Grande : Plant

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

No

MEDICAL SURVEILLANCE:

Yes

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Follow Us:

Facebook at https://www.facebook.com/AbbottCareers

LinkedIn at https://www.linkedin.com/company/abbott-

YouTube at https://www.youtube.com/c/abbott

Twitter at https://twitter.com/AbbottNews