Posted on Dec 12, 2018 by Affinity Executive Search
* Directs and prioritizes the equipment reliability of multiple laboratories within the QC department to provide for the timely and accurate testing to demonstrate that product meets company and FDA regulatory quality requirements.
* Coordinate the training and development of department personnel.
* Assignment of personnel Goals & Objectives. Perform personnel reviews and administer disciplinary actions as required.
* Promote a positive work environment for personnel morale and achievement of goals & objectives. Address personnel issues with assistance from Management and Human Resources.
* Prioritize and track progress of daily activities in functional area for timely release of equipment, for testing of products and components.
* Perform the role of Subject Matter Expert for the incorporation and maintenance of Data Integrity aspects of all testing laboratories. Act as Administrator for data collection Systems
* Assure that the integrity of materials, products, components and data is maintained.
* Assure staff conformance with cGMP and company procedures and policies.
* Support investigations and corrective/preventative actions for the Company.
* Provide technical guidance on existing and improvements to processes, products, procedures and methods.
* Develop and maintain department budget.
* Compile information required for Management Reviews and Audit Responses.
* Represent department at meetings.
* Provide a work environment for the development of people, the improvement of processes, and the achievement of personal, departmental, and company goals.
* Provide assistance to the organization within areas of expertise as needed.
* Provides evaluation and quality control recommendations for new processes relevant to equipment concerns or to troubleshoot existing processes.
* Stays current with new and changing analytical chemistry requirements, methods, and pharmaceutical changes.
* Works with peers within the site and/or at other sites to develop and harmonize processes and procedures to improve/enhance the compliance, capability, and capacity
* MS with Three years or more related experience, or a BS with five years or more related experience including two or more years as a Supervisor or above.
* Must possess skills for solving analytical problems.
* Must have working knowledge of cGMPs, GLP, ICH and USP guidances and regulations.
* Good communication skills and leadership skills are required
* Strong interpersonal skills and the ability to be highly effective in team settings.
* Strong project management skills