Documents Coordinator

Abbott • Columbus, OH

7d • Onsite

About The Position

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. At Abbott, you can do work thatママ matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. The Documents Coordinator is responsible for auditing and assuring the accuracy of batch records to be compliant with policies, procedures, and regulatory requirements. This role ensures compliance to Federal Regulations pertaining to Low Acid Canned Foods, Infant Formula Act, Acidified Foods, Nutritional Labeling Laws, and Good Manufacturing Practices.

Requirements

• High School Diploma / GED
• Minimum 2 years of QA experience
• Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals.
• Thorough knowledge of the manufacturing process including Analytical, Processing, Filling and familiarity with FDA and IFA regulations.
• Ability to analyze and trouble shoot complex problems and question data.
• Strong communication and writing skills
• Proficient in computer applications
• Ability to prioritize workload to meet business needs

Nice To Haves

• Bachelor’s degree in a technical field preferred
• 1+ year of experience as a Batch Records Coordinator
• A thorough knowledge and ability to audit all batch records preferred.

Responsibilities

• Responsible for implementing and maintaining the effectiveness of the quality system.
• Determine appropriate release criteria and communicate with DQA, PR&D, and 3rd Party Manufacturers on document requirements, documentation guidelines and audit discrepancies.
• Initiate Exception Reports (ERs) and Plant Information Reports (PIRs) and route for disposition.
• Enter and maintain work orders, ERs and Standard Quality Evaluations (SQEs) into the Release Batch Activity (RBA) system.
• Use of CAMBAR and AMAPS to adjust or obtain release status for specific batches.
• Audit and maintain records on non-batch related items (i.e.: Storage Temperature Logs).
• Coordinate isolations, holds, and reworks.
• Resolve discrepancies and deviations prior to final review.
• Reconcile product inventories with the amount of product that was manufactured.
• Track and report quality statistics.
• Assist and backup coordinators and auditors when needed.
• Train and provide work for contract workers.
• Responsible to train new employees where needed.
• Assist Supervisor as business needs dictate.
• Ensure holds and isolations have been initiated and address as required and verify all sort/destruct issues are completed and documented in work order.
• Complete final batch review of work orders ensuring all critical items are in compliance with regulations before submission to Supervisor when needed.
• Enter corrections and correction plans into GQMS.
• Coordinate product impact brackets as needed.
• Assist with the coordination of the surveillance testing program at the plant.
• Coordinate and communicate release timing of batches to meet release goals.
• Assist with completion of Certificates of Analysis.
• Responsible for coordinating and documentation of Surveillance testing, hold actions and rework and release of product.
• Errors can result in FDA observations, Corporate Compliance Audit Observations, OSHA, Recall or other regulatory action.
• Demands excellent time management and organizational skills to meet deadlines.
• Product must be released by the target launch date or shipment to customers may be delayed and in turn can negatively impact wholesale and retail business.
• Customer dissatisfaction and possibly loss of customer accounts could also result if a late batch release were to deplete product inventory.

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
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED