Manager of Quality Systems

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Primary Objectives:
The Plant Quality Systems Manager has responsibility for managing and improving the ongoing batch log auditing and product release system, managing and improving plant quality control systems including document change control and addressing nonconforming materials and other quality issues with DQA, Process Authority, Medical, R&D and other appropriate groups outside the plant environment. The Quality Systems Manager also manages the CAPA and Complaint processes for the plant, including system training and appropriate metric reporting.
Major Responsibilities:
Responsible for implementing and maintaining the effectiveness of the quality system.
Manages the Documentation System: Manages and improves the QA Work Order system. Manage and improves document routing system to assure timely implementation of requested change. Assures that all QA documents meet established divisional, corporate and regulatory standard and that these documents are an efficient, effective system for both the use and Quality Assurance. Reviews applicable change requests in order to identify documents affected and appropriate parties review the document prior to implementation. Assures that all QA documents are current. Identifies gaps in Plant Documentation and Systems and take necessary actions to correct.
Manages the Batch Log System: Audits all batch records to assure that the batch files comply with all policies, procedures and regulations effecting the product. Provides Batch Log trend information to the plant and Division. Develops systems to track, trend, report and reduce nonconforming situations. Identifies all batch nonconformance and initiate appropriate actions for those nonconformances. Assures that continuing nonconformances have follow-up action plans to correct the problem. Manages corrective action plans with supervisors and managers for discrepancies of problem areas. Assures validation requirements are fulfilled on plant wide changes prior to product release.
Controls Release of Product to Market and Quality Hold Program. Issues Finished Product Shipping Releases in a timely manner for all conforming material goods. Maintains the plant hold list consisting of nonconforming raw materials and finished product. Reports status of materials not meeting normal release times (Hold List or Delayed Release List). Coordinates priority finished product releases with Manufacturing and Logistics. Interfaces with third party manufactures of Abbott products to assure same internal Quality Standards are maintained during the manufacture of product.
Provides Liaison to the Division Staff as follows: Coordination of requests for destruction and rework of materials. Provides follow-up investigation and tracks plant related complaints for trends. Coordinates in-plant execution of the Divisions product surveillance program. Develops and issues quality reports related to problems, routine QA data, and those systems under Quality System?s responsibility.
Provides plant support as follows : Develops and executes annual audit plans as assigned. Meets with and defends plant positions to all regulatory agencies and auditors as required. Provides corrective actions and feedback where appropriate.
Conducts performance reviews; develops growth plans; interprets, implements and supports
employee-related policies, procedures and programs. Assigns projects/tasks to direct staff.
Assures compliance to all procedures and policies concerning all areas of quality, regulatory, safety and human resources for all departments.
Accountable for payroll and expenses totaling around $1MM. The Quality Systems Manager assures that all documents and operations in the plant are in compliance with the standards established by Abbott and other regulatory agencies. Job functions include final disposition of all manufactured products valued at over $100 million annually. Failure to up hold these standards could result in product recall, loss of market share and/or consumer endangerment.
Accountable for the following:
+ Determination of what product conforms to release criteria and what product is nonconforming.
+ Determination of what procedures/policies meet outside agency and internal requirements.
+ Make decisions on issues affecting proper GMP and documentation practices.
+ Setting plant standards regarding Good Manufacturing Practices.
+ Managing the Plant Documentation System.
+ Manage the CAPA and Complaints processes for the Altavista Plant
Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals.
Five years of relevant experience in Quality Assurance and/or Manufacturing. The Quality Systems Manager must have technical knowledge and demonstrate proficiency in processing technologies, filling technologies, statistics, chemistry, microbiology, computers, aseptic technologies, and written communications skills. A solid working knowledge of Low Acid Food Regulations, Infant Formula Regulations (as applicable), Kosher Laws, Corporate Policies, Divisional Policies and Guidelines, Plant procedures and other governmental (local or federal) regulations affecting the manufacturing and distribution of the products produced at the Altavista plant is required for success in the position.
The Quality Systems Manager has the authority to stop production and isolate product due to inferior quality. Document implementation requires a full understanding of various levels of company documents and regulatory issues. This individual needs to be able to communicate well and decide how information needs to be shared with outside agencies.
Bachelor Degree required; Technical Area Preferred. Low Acid Food School required. The incumbent must effectively communicate with all plant manufacturing groups, plant Quality Assurance groups, plant management, Division Quality Assurance, Logistics, Material Control, R&D groups, RS groups and Process Authority on technical subjects effecting product release to market.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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