Compliance Team, Inc.

Design Control Consultant

Job Locations US-TN-Nashville
Posted Date 1 week ago(3/15/2018 11:45 AM)
# of Openings


Compliance Team, Inc. is a leading provider of technical consulting services to our clients in the pharmaceutical, biotechnology, and medical device industries in the areas of commissioning, qualification, validation and regulatory compliance.  We are proud of our talented professionals and the major contributions they make to our clients’ successes on mission critical projects.


One of our clients is looking to remediate their quality management system focusing on:

  • Design History File (DHF)  Including, both Design Validation and Design Verification
  • Device Master Record/Device History Record
  • Software (i.e. device) validation (not validation of the manufacturing systems – software of the device itself)


  • Writing and executing validation documents
  • Investigation and resolution of validation discrepancies during the execution of protocols



  • Minimum of 2 years experience in FDA related manufacturing or laboratory operations
  • Knowledge of FDA regulations, pharmaceutical GMPs
  • Familiar with pharmaceutical manufacturing process, facilities and equipment, calibration, IQ, OQ, PQ, and development of SOPs
  • Experience with process control applications is desirable
  • Excellent communication skills: written, oral and interpersonal
  • Must be willing to travel

In addition to the above technical competencies, ideal candidates will have a commitment to deliver quality documents and service. Candidates must be results-oriented, able to make decisions and able to prioritize work per business needs.  The successful candidate will demonstrate integrity, reliability, dedication, adaptability, innovation, and self-motivation.



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