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:

Primary Function:

Maintaining and improving the ongoing batch record review, batch release system, and batch certification processes. Address Nonconformance issues with Plant management, Division, and other appropriate groups. Maintain appropriate Key Performance Indicators and metrics as required by the site. Manage all batch release activities for the site. Implementing new and modified procedures to ensure that the plant is in compliance with FDA requirements and corporate and division policies.

Primary Goals/Objectives

Auditing all product related information and systems for compliance to Federal regulations, Abbott Corporate and Abbott Nutrition Divisional Policies and procedures. Managing the corrective and preventive action systems to assure identification and reduction of recurring quality issues regarding batch nonconformances, potential nonconformances, and quality assessments. Tracking and maintaining all Plant and Division Quality goals. Supporting the site audits from both internal and external regulating bodies. Maintaining and updating budgetary plans. Development of exempt and nonexempt employees. Developing/upholding a team environment and team related activities between all of Quality systems, focusing on batch release employees and auditing employees. Assuring that change control is maintained on all controlled documents and systems within the plant. Assuring all product related information and systems for compliance to Federal regulations, Abbott Corporate and Abbott Nutrition Divisional Policies and procedures. Coordinate batch reviews, release, and certification processes.

Major Responsibilities:

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

Incumbent will lead efforts required to deliver quality and compliance performance for the QS department. They will coach and direct individuals in delivering performance required for themselves, their team and the department. He/she will actively participate in internal and external quality audits and incident investigation and reporting; coupled with timely implementation of corrective and preventive actions.

Additional items:

Review all 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. Provide Batch Record trend information to the plant and Division. Store and maintain all batch files to comply with Corporate and Division policies in a State of audit readiness. Identify all batch non-conformances and initiate appropriate actions for those non-conformances. Assure that continuing non-conformances have follow-up action plans to correct the problem.  Manage corrective action plans with Front Line Leaders (FLLs) and managers for discrepancies of problem areas. Manage corrective action plans with FLLs. Assure validation requirements are fulfilled on plant wide changes prior to product release. Issue Finished Product shipping releases in a timely manner for all conforming material goods. Manage the tracking and reporting of materials not meeting normal release times (Hold List). Coordinate priority finished product releases with Manufacturing and Logistics. Coordinate requests for rework and destruction of materials. Coordinate surveillance batch execution for Division. Develop and issue quality reports related to problems, routine QA data, and those systems under QS responsibility. Assure all required training is provided and completed by all dept. employees. Develop exempt and nonexempt employees on implementation of all documents. Assist in creating and modifying plant documents to meet the plant needs. Managing the use, editing and addition of controlled documents as required by FDA and CFRs documentation. Provide plant support for DQA, Division and Corporate in the development of production documentation. Manage exempt and nonexempt QS personnel, responsible for training and development. Store and maintain all files to comply with Corporate and Division policies in a state of audit readiness. Conduct annual performance reviews with all direct reports.

Education:

Indicate the minimum education and why it is required.

 MAJOR(S)

Bachelor’s Degree/Technical Area Preferred or equivalent experience

Certifications:

Low Acid Food School, required

Background:

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

5+ years of relevant experience in Quality Assurance and /or Manufacturing required.

Prior Supervisory experience desired                                                                                                   

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Problem Solving:

The QS Batch Release FLL has the authority to stop production and isolate product due to inferior quality.  These types of decisions need to be made quickly to minimize cost and reduce risk.  The QS Batch Release FLL is also responsible for assuring that all document changes, policies, and procedures are in effect for all changes that occur to all documents.  They must initiate or coordinate changes, route to necessary people for approval, implement and make sure all other necessary pieces of the change are in place at the same time.  These types of decisions need to be thorough to minimize cost and reduce risk.  This individual needs to be able to communicate well and decide how information needs to be shared with the appropriate groups. 

The incumbent must effectively communicate with all plant manufacturing groups, plant Quality Assurance groups, plant management, Division Quality Assurance, Logistics, Material Control, PR&D groups, AR&S groups, and Process Authority on technical subjects effecting product quality and plant operations.

The incumbent should have some technical knowledge in the areas of processing, filling, statistics, aseptics, chemistry, microbiology, computers, product drying technologies and written communication skills.

 A good working knowledge of Low Acid Food Regulations, Infant Formula Regulations, Corporate Policies, Divisional Policies and Guidelines, Plant procedures and other governmental (local or federal) regulations affecting the manufacturing and distribution of the products at the plant is required for success in this position. 

This body of knowledge allows the Quality Systems Batch Release FLL to make sound business decisions regarding the manufacturing and quality disposition of batches.  The responsibilities of this job affect all products manufactured at the facility.    

Accountability / Scope/Budget:

Describe the primary accountabilities of the position and the impact of actions.

Accountability:

The QS FLL assures that all batch work orders are in compliance with the standards established by Abbott Nutrition and other regulatory agencies before product is released to market.  Failure to uphold these standards could result in product recall, loss of market share and/or consumer endangerment.  The QS Batch Release FLL is also responsible for managing the plant and Division performance goals, Quality Hold Program, plant formulations and document changes development of nonexempt personnel.

Scope of Authority:

Describe the freedom and limit of individual action by the incumbent and the amount and type of supervisory review.

The incumbent’s scope of authority encompasses:

Act on the part of the Plant Quality Systems Manager during his/her absence. Direct communication with Division Quality Assurance when required. Make decisions on issues affecting batch quality. Manage the plant Quality goal system. Address nonconformances through the CAPA systems. Make decisions on issues affecting document system.

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Travel: No
Medical Surveillance: No
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)