Quality Control Supervisor

Endo•Raleigh, NC

1d•Onsite

About The Position

Responsible for managing day-to-day testing activities of the Quality Control group. This includes direct supervision of QC Technicians. Manages functional, day-to-day aspects of the Quality Control Department such that all Quality Control metrics, internal customer support, and individual/department goals are achieved. Supervises Quality Control personnel such that all of their individual and team objectives are met in support of the Departmental Objectives.

Requirements

A Bachelor of Science degree in Chemistry or other Life Sciences or equivalent work experience of greater than 8 years.
With relevant degree 5 years of applicable Quality experience is preferred; without a degree 8 years plus of applicable Quality experience is required.
Experience with Mallinckrodt QC Testing laboratory is preferred.
Must have a sound understanding of general analytical chemistry techniques and principles and a general knowledge of chemical synthesis in order to understand plant processes and determine testing techniques that meet Plant needs.
A general knowledge of statistical principles is required to assure accuracy, reproducibility, and validation of methodology and personnel.
A thorough understanding of Current Good Manufacturing Practices and Q7A is required to assure compliance.
A good understanding of site policies for safety and environmental concerns is needed.
Must have a sound understanding of proper personnel policies.
Must have sound management and organization skills in order to manage the functional operations of the Lab as well as all departmental personnel.

Responsibilities

Manages functional, day-to-day aspects of the Quality Control Department such that all Quality Control metrics, internal customer support, and individual/department goals are achieved.
Supervises Quality Control personnel such that all of their individual and team objectives are met in support of the Departmental Objectives.
Directs the work of Quality Control Technicians to meet routine and ad-hoc testing needs for the Raleigh Mallinckrodt site.
Handles administrative and personnel issues of the Quality Control Technicians especially with regards to resource allocation and testing adherence. Review and approve time card entries and time off requests.
Manages all controllable cost items such that spending is at or below budget, including overtime scheduling/tracking.
Manages the technical training and personal development of Quality Control Technicians. Delivers performance reviews periodically to ensure that all individual and departmental goals are met.
Monitors laboratory activity for compliance with Good Manufacturing Practices and Good Laboratory Practices including instrument calibration and maintenance, Procedure/Method adherence, and facility/equipment conditions.
Utilizes Quality Management System to enter and investigate Exceptions and Out of Specification results to support product disposition. Create and complete corrective/preventive action plans or improvements as necessary.
Continuously implements improvements to make the Quality Control Lab run more efficiently and cost effective.
Serves as a QC technical resource to support investigation of Manufacturing Plant problems and improvements.
Provides support for QC department during internal, corporate, and external regulatory agency audits. Participates in audits and laboratory tours.
Assumes responsibilities of the QC Manager duties in their absence.
Assists other QC Department members to act as back up for QC programs such as Finished Goods Release, Laboratory Hazardous Waste Program, Chemical and Testing Supplies Inventory, or Stability Program as assigned by the QC Manager.
Conducts in-process, raw material, finished goods, and/or waste water testing as needed.
Other duties as assigned with or without accommodation.