• Quality Shift Lead - Bioassay

    Job Locations US-GA-Union City
    Job ID
    Quality Control
  • Overview

    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


    • Scope:
    • 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.



    Job Requirements:

    • 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.
    • Knowledge of cGMP/ICH/FDA regulations.
    • Proficient in MS Office applications.


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