Quality Systems Supervisor - Abbott Laboratories : Job Details

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

The Quality Systems/NPI FLL is responsible for resolving issues related to workorder, processing, filling and release of products. The Front Line Leader is responsible for managing work schedules, budgeting overtime, communicating issues to logistics and production planning that may lead to late product releases.

• Review and issue all work orders, policies, and procedures to assure that they comply with all policies, procedures and regulations affecting the product. This includes the Food GMP's, Kosher Law, and Low Acid Food Regulations.
• Store and maintain all document files to comply with Corporate and Division policies in a state of audit readiness
• Responsible for having necessary documents in place for a new product introduction or formulation change.
• Manages the integration of New Product Introduction (NPI) into Quality System
• Responsible for the on time and right first for new products introduced to the plant
• Acts as the liaison between the plant and division for new product introduction projects
• Address document issues with Plant management, Division and other appropriate groups.
• Supporting the FDA, Corporate Compliance and Plant Sanitation and Housekeeping audits.
• Provide document information to the plant and Division.
• Coordinate surveillance batch execution for Division.
• Develop and issue quality reports related to problems, routine QA data, and those systems under QS responsibility.
• Develops systems to track, trend, report and reduce Nonconformance issues.
• Identifies all batch non-conformances and initiates appropriate actions for those non-conformances.
• Assures validation requirements are fulfilled on plant wide changes prior to product release. Conducts performance reviews; develops growth plans; interprets, implements and supports employee-related policies, procedures and programs.

Assigns projects/tasks to direct staff.

Education:

Bachelor's degree required in Business, Science Technical Field or equivalent experience.

Background:

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

The incumbent must have good written and verbal communication skills. They must possess strengths in the Abbott core competencies. This individual must have good organizational skills and be able to multi- task, drive for results and make sound business decisions independently.The individual should have 2 -5 years of relevant experience in Quality Assurance and/or Manufacturing plus 2 years Supervisory experience preferred. Some technical knowledge/experience is preferred, especially in the area of mixing, statistics, chemistry, and microbiology. A good working knowledge of Food Safety Regulations, Division and Corporate Policies, and the manufacturing and distribution of the nutritional products.

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.

Accountability / Scope/Budget:

This position directly impacts the plant's financial goals for releasing product to market and meeting product launches and schedules.The Front Line Leader is responsible for meeting departmental budgets.This individual acts on behalf of Quality Systems when the Quality Systems Manager is not present.

The base pay for this position is $60,000.00 – $120,000.00. In specific locations, the pay range may vary from the range posted.