Check with seller MANAGER, CHEMISTRY Wilson

  • Location: Wilson, North Carolina, United States


Job Summary
The Manager, Chemistry will be responsible for the management of all activities associated with testing of raw material and finished goods to meet established and expected quality, regulatory and customer requirements. Interact with Manufacturing and Quality Assurance on a routine basis.
Responsibilities
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

Directs and prioritizes the functioning of multiple laboratory work teams within the department to provide for the timely and accurate testing of raw materials, in-process and finished goods, to demonstrate that product meets FK USA and FDA regulatory quality requirements.
Oversees the administration of staff to ensure that members are adequately trained, developed and motivated, and that they adhere to quality performance standards.
Plans and coordinates training schemes leading to the development of cross-trained, self-directed work teams in line with total quality management concepts.
Stays current with new and changing analytical chemistry requirements, methods, and pharmaceutical changes.
Evaluates and decides upon corrective actions to be taken in response to OOS or OOT situations.
Provides evaluation and quality control recommendations for new processes relevant to chemistry concerns or to troubleshoot existing processes.
Assists in the development, administration and maintenance of the operating and capital budgets for the department.
Represents the department with active participation in cGMP inspections and other audits as required.
Coordinates departmental staffs so that all departmental obligations conform to cGMP and FK USA policies and procedures.
Provide assistance to the organization within areas of expertise as needed.

Provide a work environment for the development of people, the improvement of methods, and the achievement of personal, departmental, and company goals.
Participate in the review of annual product review documents related to the department.
Provide a work environment for the development of people, the improvement of processes, and the achievement of personal, departmental, and company goals.
Attends and represents the department at the applicable management review meeting.

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