QC Head

• Execute and review analytical quality control release, stability and complaint (follow-up) testing for raw materials, in-process and final products to ensure compliance with cGMPs, GLPs, ISO Quality Assurance Procedures, SOPs and established deadlines

• Establish and maintain a comprehensive QC training program for analytical personnel and reinforce the training with appropriate assignment(s) and delegation of responsibility

• Monitor and prepare formal evaluations of employee performance to ensure continued compliance

• Ensure safe operations in the laboratory

• Coordinate transfer of methods (new/alternate, customer supplied (ILQ) or improved methods) or technology (instruments) into the QC laboratory 

• Train QC analysts on new/improved instruments and test methods

• Identify, procure, install and qualify required QC instrumentation and equipment 

• Establish and maintain laboratory programs to monitor and evaluate systems or equipment (i.e. analytical instrument and equipment, etc.) status, ensure efficient laboratory performance and compliance with preventive maintenance, qualification, and calibration schedules

• Establish and maintain laboratory programs to process, monitor and evaluate the status of test (release, complaint, or investigation) samples in the Quality Control Laboratory to ensure efficient laboratory throughput 

• Oversee and allocate personnel required to ensure deadlines are met

• Direct and close all QC Stage 1 OOS investigations, deviations, CAPA, and QA investigations within established target dates

• Oversee and continuous improvement of FDA compliant Quality System

• Manage the team including mentoring and coaching of staff, establishing priorities, and delivering projects within budget and on time

• Use a team-oriented approach to problem resolution

• Other duties as assigned

Work Conditions: