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      Job Posting: QC Chemistry Lab Manager

      Indianapolis, IN

       

      Position Overview

       

      Responsible for managing and setting the direction of the QC Laboratory operations (Chemistry) in a cGMP environment. This employee's main responsibility is to assure the reliability of all data generated by the Quality Control Laboratories and the safety of all personnel.

       


       

      Major Position Activities & Responsibilities

       

      • Responsible for the supervision, training and development of Chemistry staff
      • Support of timely analytical testing required for the Stability Program.
      • Trend analysis of critical system data
      • Management of the budget for the chemistry laboratory
      • Responsible for environmental, health, and safety compliance
      • Communicate with Manufacturing, Facilities, Quality Assurance and other external departments on analytical operational issues
      • Serve as analytical QC reviewer of test data packets for product release, stability, validation protocols, special test requests and special studies.
      • Represent QC laboratory in a technical expert capacity on analytical methods when required
      • As a part of the employee’s job requirements, the employee may be required to handle wastes, including hazardous wastes. The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training.
      • Perform special projects and other duties as assigned.

       


       

      Scope

       

      This position will have responsibility for one supervisor, one instruments specialist, and several analysts as direct reports. The QC Chemistry lab manager will be responsible for the reliability and validity of all analytical-generated data, assuring laboratory adherence to all validated methods, to applicable regulations and to the business plan. This employee will also be responsible for maintaining the budget and monitoring capital expenditures.

       


       

      Background Qualifications

       

      • B.S. degree with a major in Chemistry. (Masters preferred)
      • Eight years or more of experience in a pharmaceutical manufacturing Chemistry Lab
      • Five years or more experience in management or supervision.
      • Knowledge of QC systems operations, expertise in a GMP testing/manufacturing environment, and experience with analytical method validation for analytical techniques
      • Microbiology and environmental systems operations experience in an aseptic environment is a plus but not a requirement.
      • Project management skills are essential for successful completion of extraordinary tasks.
      • Ability to communicate at all levels in a pharmaceutical organization. Good interpersonal skills are a must.

       


       
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