The Quality Shift Lead will lead a team of 7 to 8 quality analysts and be responsible for the testing of in-process and final product samples in compliance with the established procedures and quality systems
Supervises security, maintenance and operational use of laboratory equipment.
Is responsible for in-process and final product testing of clinical and commercial products.
May participate in the development of standards, methods and procedures for inspecting, testing and evaluating the quality of products.
Provides immediate supervision or assigns tasks to a shift of employees. Provides general or direct supervision to exempt employees and/or skilled nonexempt employees. A portion of the time may be spent performing individual tasks.
Makes recommendations for corrective action necessary to ensure conformity with quality specifications.
Ensures finished products conform to company standards and satisfy GMP regulations.
Acts as advisor to management and becomes actively involved as required to meet schedules or resolve problems.
Represents QC in cross-functional teams and projects upon request.
Selects, develops and evaluates personnel to ensure functional objectives are met.
Other duties as assigned
Works on problems of moderate scope in which analysis of situation or data requires review of identifiable factors. Exercises judgment within defined procedures and policies to determine appropriate action.
Frequently interacts with direct reports and functional peer groups.
Uses professional concepts and company policies and procedures to solve a variety of problems.
Exercises judgment within defined procedures and practices to determine appropriate action.
Demonstrates strong verbal and written communications skills and the ability to negotiate with internal and external customers.
Bachelor’s degree in a scientific discipline or equivalent.
Demonstrated leadership and managerial skills in pharmaceutical industry setting.
Work well in team setting and fast-pace work environment.
Demonstrated work schedule flexibility including working on night shift.
Typically >5 years of related experience in cGMP/FDA regulated industry, preferably in lab setting
Prefer >2 years of trainer experience
Excellent interpersonal skills and demonstrated dedication to get job done.