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Batch Records Auditor

Company: Abbott Laboratories
Location: Mishawaka
Posted on: September 25, 2022

Job Description:

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 113,000 colleagues serve people in more than 160 countries.Primary Function / Primary Goals / Objectives:The QA Specialist is responsible for maintaining and improving guidance documents and (Work Orders, Forms, Procedures, etc.) and supporting the overall Quality Systems Department. Major Responsibilities:The QA Specialist assists in development and execution of New Product Introduction (NPI) activities including tracking and trending and communication of NPI needs and/or trends to the leadership and support staff as appropriate. He/she develops master work orders, plant procedures, Deviations and orders first lot to stock deviation testing as necessary in support of plant projects, new processes, and new packages.Assures that all documentation is in compliance with standards established by Abbott and other regulatory agencies before it is released for review and final approvals. Incumbent must possess the abilities to work with an experienced Sr Project Leader, Quality Engineer, or Manager in identifying quality issues and approaches to their resolution. This position requires moderate Supervision. This position addresses documentation concerns with Plant management. Responsible for implementing and maintaining the effectiveness of the quality system and providing support to Quality and Compliance Management to ensure Plant regulatory compliance. He/she also participates in, and supports successful completion of regulatory Audits and assessmentsThis position will assist the site by authoring deviations, assuring the appropriate information and attachments are accessible in the CAPA system.This position may also acts as an alternate for the Batch Records function which Audits batch records to assure that the batch files comply with all policies, procedures, and regulations effecting the product. This includes the Infant Formula Regulations, Food GMP's Kosher Law, and Low Acid Food Regulations.As an alternate he/she identifies all batch nonconformance and initiates appropriate actions for those non-conformances, when needed, and issues Finished Product shipping releases in a timely manner for all conforming material goods.Education:Indicate the minimum education and why it is required.Bachelor's Degree preferred or relative work experience. Degree in a Technical area such as Engineering or Food Science preferred. Individual needs to communicate effectively with people in Engineering, Manufacturing, Research and Development, Logistics, Material Control, and plant management.Background:Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals is necessary.Two years of relevant experience in Quality Assurance and I or Manufacturing or Engineering. The individual needs to be able to communicate well and decide how information needs to be shared with the appropriate groups.This position requires knowledge of various plant processes in order to identify the causes of problems with product quality as well as potential concerns during product launches. Application of knowledge to solve problems with product quality is required. The individual must use sound technical judgment in reaching valid conclusions that will be regularly audited by Division and Corporate Auditors. The individual will also be self-driven with the ability to work independently with little Supervision and capable of driving actions forward to meet Plant deadlines for Project Goals.A good working knowledge of Low Acid Food Regulations, Infant Formula Regulations, Corporate Policies, Division Policies, Plant procedures and other governmental regulations affecting the manufacturing and distribution of the products produced in the plant is required for success in this position.

Keywords: Abbott Laboratories, Mishawaka , Batch Records Auditor, Accounting, Auditing , Mishawaka, Indiana

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