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GLP GCLP Senior Consultant (Hybrid)

Pace Analytical Services, LLC
United States, Maryland, Frederick
4539 Metropolitan Court (Show on map)
Feb 10, 2025

Job Description: We are seeking an experienced GLP and GCLP Consultant to join our dynamic team. The ideal candidate will have a strong background in regulatory compliance within the pharmaceutical, biotechnology, or related industries. As a GLP and GCLP Consultant, you will provide strategic advice and hands-on support to ensure our clients' laboratory operations meet or exceed regulatory requirements.

Key Responsibilities:



  • Conduct comprehensive audits of laboratory processes and facilities to ensure compliance with GLP and GCLP regulations.
  • Develop and implement GLP and GCLP training programs for laboratory staff.
  • Advise clients on the design and execution of GLP and GCLP-compliant studies.
  • Prepare and review GLP and GCLP documentation, including standard operating procedures (SOPs) and study protocols.
  • Assist in the preparation for regulatory inspections and audits.
  • Stay up-to-date with changes in GLP and GCLP regulations and industry best practices.
  • Provide ongoing support and guidance to clients to maintain GLP and GCLP compliance.


Qualifications:



  • Bachelor's degree in a scientific discipline; advanced degree preferred.
  • Minimum of 15 years of experience in a GLP and GCLP-compliant environment.
  • In-depth knowledge of GLP and GCLP regulations and industry standards.
  • Excellent analytical, problem-solving, and communication skills.
  • Ability to work independently and as part of a team.
  • Strong organizational skills and attention to detail.


Pace Life Sciences

Pace makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&D through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace provides professional services to support their operations.

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