Batch Record Auditor - Casa Grande, AZ

Batch Record Auditor - Casa Grande, AZ at Abbott Laboratories summary:

The Batch Record Auditor at Abbott Nutrition in Casa Grande, AZ audits production and batch records to ensure completeness, accuracy, and compliance with plant procedures, GMP, FDA, OSHA and company policies. Responsibilities include verifying documentation, logging discrepancies, initiating holds/samples, maintaining auditing databases, and supporting data collection and reporting. Requires HS diploma/GED, manufacturing/process knowledge, computer proficiency, analytical and communication skills; technical degree and Low Acid Food certification preferred.

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 114,000 colleagues serve people in more than 160 countries.

BATCH RECORD AUDITOR - Casa Grande, Arizona

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. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• 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.

The Opportunity

This position works out of our Casa Grande, Arizona location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives.

Casa Grande, AZ., is one of Abbott’s leading nutrition manufacturing plants in the U.S., reflecting our commitment to innovation and excellence. But we’re more than just a company, we’re a family. Working here you’ll be part of a family that works together to make a difference and enhance the lives of millions worldwide.

What You’ll Work On

• 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.
• 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.
• Reviews work orders for completeness and compliance to all policies, procedures, IOP requirements and Government regulations.
• 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, Discrepancies and Alert levels into the auditing system.
• Ensures holds and isolation have been initiated as required.
• Works with appropriate personnel for batch sampling plans, initiate sample requests, write inspection and reworks.
• Audits and maintains records for non-batch log related items (i.e.: Tank Temps, CIP charts)
• Provides support for data collection.

You’ll be accountable for meeting our compliance standards including FDA, OSHA and Abbott policies and procedures.

Required Qualifications

• High School Diploma or GED
• A thorough knowledge of the manufacturing process including Analytical Processing, and Filling
• Proficiency in computer applications
• Ability to work independently
• Must have the ability to analyze and trouble shoot existing/potential problems
• Have strong communication and writing skills and the ability to prioritize workload

Preferred Qualifications

• Bachelors’ degree in a technical field
• Certification in Low Acid Food processes

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 (eeoc.gov)

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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

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 and Military/Veteran friendly Employer, committed to employee diversity.

Connect with us at , on Facebook at , and on Twitter @AbbottNews.

The base pay for this position is $19.05 – $38.15 per hour. In specific locations, the pay range may vary from the range posted.

Keywords:

batch record auditor, GMP compliance, production record review, quality assurance, FDA compliance, manufacturing audit, discrepancy management, batch sampling, auditing database, food manufacturing