ABBOTT LABORATORIES Quality Systems Document Supervisor- Columbus Plant Salary in the United States

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 109,000 colleagues serve people in more than 160 countries.

Quality Systems Supervisor

The Quality Systems Supervisor is responsible for maintaining and improving all functions of the Documents and Batch Records groups.  This position is responsible for final release of product to market and assuring batches meet applicable regulations and division standards, as well as the entire document control function.

Major Responsibilities:

Responsible for implementing and maintaining the effectiveness of the quality system. The Quality Systems Supervisor is responsible for resolving issues related to work order, processing, filling and release of products.  The Supervisor is responsible for managing work schedules, budgeting overtime; communicating issues to logistics and production planning that may lead to late product releases.

• Maintaining and improving the ongoing document change control process.
• 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 Infant Formula
• Regulations, 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.
• Address document issues with Plant management, Division and other appropriate groups.
• Supporting the FDA, Corporate Compliance and Plant Sanitation and Housekeeping audits.
• Maintaining and updating budgetary plans.
• Provide document information to the plant and Division.
• Issue all documents in a timely manner.
• Coordinate surveillance batch execution for Division.
• Develop and issue quality reports related to problems, routine QA data, and those systems under QS responsibility.
• Conduct annual performance reviews with all direct reports.
• Manage performance development plans for all direct reports.
• Assure all required training is provided and completed by all dept. employees.
• Promote and support team development activities.

Education and Required:

• Bachelor's degree required in Business, Science Technical Field or equivalent experience.
• The individual should have 2 -5 years of relevant experience in Quality Assurance and/or Manufacturing plus 2 years Supervisory experience preferred.
• The incumbent must have good written and verbal communication skills.
• This individual must have good organizational skills and be able to multi- task, drive for results and make sound business decisions independently. 
• A good working knowledge of Food Safety Regulations, Division and Corporate Policies, and the manufacturing and distribution of the nutritional products. 

Preferred:

• Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals.
• Some technical knowledge/experience is preferred, especially in the area of mixing, statistics, chemistry, and microbiology.