Plant Analytical Lab Manager

Abbott   •  

Altavista, VA

Industry: Biotech/Pharma


8 - 10 years

Posted 393 days ago



Primary Function

An Analytical Lab Manager is responsible for and is an active leader in ensuring major objectives are met. Major objectives include: assuring regulatory compliance, meeting production schedules, creating and maintaining a high level of employee relations, satisfying all customer service needs, and ensuring budgetary and financial goals are met. An excellent understanding of the manufacture of products is required, as well as expert knowledge of the Processing and Analytical areas. 1. Chemical and physical testing of ingredients, in-process, finished product and various environment/utility tests. 2. Corrective action/preventive action (CAPA) for recurring deviations. 3. Laboratory method and document review. 4. Continuous improvement of laboratory efficiency and productivity. 5. Training and managing of supervisors, team leaders and chemists in the analytical laboratory. 6. Managing the department budget. 7. Decision making. 8. Technical resource for the plant and technical liaison for other business units.

Main Responsibilities

Responsible for implementing and maintaining the effectiveness of the quality assurance dept. more specifically:
Assure that all ingredient, in-process, finished product, packaging and environmental testing is performed according to established requirements and that all results are compared to specific standards.
Ensure adequate training and direction for all subordinates.
Review non-conformances that impact the Analytical and Incoming Materials labs and provide recommendations and corrective action.
Comply with Infant Formula regulatory requirements, assuring that all analytical testing conforms to these regulations and results meet the required nutrient levels.
Manage the financial needs of the Analytical and Incoming Materials labs, such as headcount, expense, capital requirements, etc.
Strive for improved efficiency and effectiveness of analytical and incoming materials testing procedures and their impact on production operations.
Manage human resources in the Analytical and Incoming Materials labs, including employee development, employee counseling, hiring, firing, etc.

Accountability / Scope / Budget

The Manager, Analytical and Incoming Materials Laboratory reports directly to the Manager, Plant Quality Assurance.
The Analytical and Incoming Materials Laboratory manager’s responsibility impacts all nutritional products produced in the plant 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.

Minimum Education & Experience

Bachelors Degree Chemistry or closely related area Masters Degree Chemistry (preferred but not required)   Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals. Knowledge of food processing. Statistical applications. (4-6 years of experience) Supervisory/leadership (2-4 years of experience) Combined years of experience 7 years.