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Batch Record Reviewer Day Shift Columbus Plant
4 months ago
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.
Nourish the world and your career as part of the Nutrition team at Abbott.
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 get the nutrients they need to live their healthiest life.
Our plant location in Columbus, OH currently has an opportunity for a Batch Records Coordinator. This site is Abbott's oldest nutrition manufacturing plant in the world. Working here, you'll feel part of a family - a family of 400 that works together to help nourish the world.
What you will do as a Batch Records Coordinator: Quality Records Auditor
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 WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
- 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
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
- Vacation - 3 weeks of accrued vacation (1st yr is prorated) + vacation buy program + 3 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 bachelor's 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 company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
- A stable company with a record of strong financial performance and history of being actively involved in local communities
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.
- The Auditor is responsible for the complete audit of the work orders in Quality Systems.
- This position is accountable for complying with applicable FDA (GMP), USDA, OSHA and Abbott/Ross regulations, policies, procedures or guidelines.
Experience and Education You''ll Bring:
Required:
- Strong independence
- Strong attention to detail
- 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.
Preferred:
- 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
Learn more about our benefits that add real value to your life to help you live fully:
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $ $36.45 per hour. In specific locations, the pay range may vary from the range posted.
