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Quality Control Manager-Columbus Plant- Analytical, Micro & IMI

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.
JOB DESCRIPTION:
Primary Function / Primary Goals / Objectives:
QC Manager are highly technical and administrative in nature and include management, implementation, and maintenance in the following areas: Responsible for managing the QC Laboratory, which is comprised of the following functions:
Chemical and physical testing of ingredients, in-process batches, finished product, Environmental Monitoring Program, Product testing, providing direction to Microbiology, Analytical & IMI Personnel; ensuring CAPA activities are followed through to completion; and providing leadership during problem solving situations.
Laboratory methods and document review.
Continuous improvement of laboratory efficiency and productivity.
Training and supervision of all supervisors, and any laboratory personnel reporting to the QC Manager.
Managing the department budget.
Technical resource within plant and technical liaison to other business units.
Major Responsibilities:
Responsible for implementing and maintaining the effectiveness of the quality system.
Assures that all lab testing is performed according to established requirements and that all results are compared to specific standards. Strives for improved efficiency and effectiveness of testing procedures and their impact on production operations.
Interfaces with division personnel in the development of Lab guidelines and specifications.
Reviews non-conformances that impact the lab and provides recommendations and corrective action.
Test results must comply with all internal standards, specifications, etc., and must comply with regulation requirements. Results outside the established limits must be reviewed thoroughly. The Manager will assist Manufacturing and other departments in preparing and implementing corrective action for those circumstances when standards are not met, and preparing product disposition recommendations in those cases. In addition, the Manager must prepare comprehensive reports on quality related problems involving the Laboratory.
Controls budget and quality costs in the manufacturing operation through preparation of headcount needs, overtime/contract labor management, direct expense/capital equipment needs, development of accurate labor standards, and comprehensive laboratory plans for short and long range outlooks.
Provides leadership to assure that all employees receive necessary training and direction to effectively execute their individual duties and responsibilities.
Performs QA document reviews to assess compliance of testing activities, uncover any problem areas and pursue corrective action with the proper departments, evaluate impact of manufacturing procedures on lab testing and product quality, and assess any needs for formulation adjustments for better control.
Makes timely and sound decisions regarding batch disposition, corrections, method suitability, personnel issues, etc.
Responsible for managing processes associated with the inspection of incoming materials.
Manages human resources in the lab, including employee development, employee counseling, hiring, firing, etc.
The Manager, Lab has a key role in plant production operations due to the manufacturing support duties that comprise this area. The Manager interacts with manufacturing areas in the plant at all levels. This position also works closely with division research and QA groups for problem solving efforts and meets with supplier representatives to discuss various problems and commodity changes.
Education:
Bachelor's Degree in Microbiology/Chemistry, or related area. Masters Degree in related area (preferred but not required).
The highly complex nature of the testing methodologies require a good, sound understanding of Microbiology/Chemistry and the critical points in all procedures.
Background:
Knowledge of applicable regulatory standards and requirements for nutritionals.
Four years knowledge of food processing techniques, laboratory procedures and documentation requirements, and statistical applications is essential.
Two years supervisory/leadership required.
This position must have good technical background and a thorough understanding of production procedures to address the daily problems that will occur.
The QC Manager must be both aggressive and creative in solving problems to avoid significant production downtime.
All chemical and physical testing that is required for ingredient acceptance and the manufacture of the product.
The QC Manager must be well versed in the theory surrounding each of the analyses, in the application of the test to the manufacturing operation, and must be capable of trouble shooting problems that arise with these methods on an immediate basis, to avoid extensive production delay and risk.
Accountability / Scope/Budget:
The QC Manager, reports directly to the Manager, Plant Quality Assurance. The QC Manager's responsibility impacts all nutritional products produced in the plant (thought-put of up to $180MM) and preservation of the company's continued well-being through compliance to regulations and avoidance of major disruptions from inspection agencies such as the FDA. Data from the manager's laboratory is the key element for assuring compliance with FDA regulations. The Manager, QC has the freedom to manage all subordinates within the confines of company policies, procedures, and established standards of conduct. This position must require a high degree of independence and must perform all tasks with a minimum of supervision form the Manager, Plant Quality Assurance.
JOB FAMILY:Operations Quality
DIVISION:ANSC Nutrition Supply Chain
LOCATION:United States > Columbus : Columbus Plant
ADDITIONAL LOCATIONS:United States > Tipp City : Main/Liquid Plant
WORK SHIFT:Standard
TRAVEL:No
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

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