The QC Lab Manager is responsible for implementing processes and overseeing all daily activities and quality systems for Chemistry, Physical, and Microbiological laboratories in the new FDA-regulated manufacturing facility in Morristown, TN. This role will ensure that lab testing provides the highest quality of analytical support for manufacturing while maintaining compliance with Regulatory and Company guidelines, cGMP requirements, and safety regulations. The successful candidate will also be responsible for leading Lab associates by example and embodying the iatric culture.
Essential Responsibilities :
The QC Lab Manager is responsible for managing the daily activities for the iatric laboratories. This includes but is not limited to the following:
* Directs all activities of the laboratory in the analyses of raw materials, finished products, in-process, and product development samples
* Interacts with vendors for purchasing lab consumables, scheduling lab equipment maintenance, and uniform services for lab coat management
* Develops, reviews, revises and approves new/revised procedures, work instructions, protocols, reports, specifications, analytical method development, validation, and transfers
* Provides leadership, management, and training to all laboratory employees
* Conducts ongoing associate assessments and recruiting/hiring of new talent
* Oversees and approves internal and external laboratory investigations
* Communicates with Operations, QA, Sales, Global Purchasing and Customers on all analytical/laboratory-related issues as well as new product support including method transfers/validations
* Assists in all internal and external quality audits and provides responses to internal and external audit observations
* Associates have a direct and important role in ensuring that all work is performed in a safe manner. Effectiveness in carrying out this responsibility is part of each associate's essential accountabilities.