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GCP Auditor

Edison-New Brunswick Metro Area, NJ

Posted: 11/06/2019 Job Type: Scientific Job Number: JN -112019-25938

Job Description

Responsibilities:

Maintains keen awareness of all audit-related matters (e.g., internal clinical program status, SOPs and other internal guidance, regulatory changes, industry trends):

  • Possesses an awareness of current and planned clinical programs within MTDA
  • Performs QA project management to deliver agreed QA coverage of projects and activities related to assigned compound(s)
  • Actively provides QA input to MTDA working groups and system(s) development as appropriate
  • Provides advice on QA and GCP matters to MTDA staff
  • Serves as primary liaison with Regulatory Affairs Dept in maintaining an awareness of ongoing regulatory changes
  • Attends relevant conferences and seminars to maintain awareness of external QA activities
  • Delivers the QA contribution to internal and external meetings (e.g. investigator meetings) as appropriate
  • As requested, develops QA SOPs
  • Provides QA review and approval of MTDA SOPs and Work Instructions
  • Reads and maintains awareness of applicable MTDA SOPs relevant to function

Performs wide-ranging audit activities:

  • Prepares audit plans for clinical and other projects as applicable
  • Liaises with relevant parties to arrange audits or reviews required by QA audit plans
  • Performs audits of MTDA's internal systems
  • Prepares reports of audits performed, per SOP(s) timelines
  • Follows up on audit observations to agreed conclusions
  • Provides audit certificates for relevant audits
  • Distributes relevant audit reports and documents in accordance with MTDA QA Policy

Liaises as required with internal/external counterparts on global activities and programs:

  • Provide local US perspectives in relation to global activities and systems
  • Liaises as required with QA representatives in other markets
  • Hosts "GXP" related audits and inspections
  • Performs other duties as required

Qualifications:

  • Bachelors degree (science major is preferred)
  • At least seven (7) years experience as a QA Auditor of the drug development process
  • In-depth experience with Good Clinical Practices (e.g., leading GCP audits and/or training staff in GCPs) is required
  • Highly analytical and detailed approach; proven ability to detect and correct errors and/or inconsistences
  • Comprehensive understanding of FDA regulations; knowledge of ICH guidance is required
  • Excellent interpersonal and communication skills; ability to build effective relationships within a team/collaborative environment, while demonstrating a high level of professionalism
  • Good written communications skills, including SOP/other technical writing
  • Able to travel as required within a global work environment (approximately 10%)

Physical Demands:

  • Ability to sit or stand for long periods of time
  • Manual dexterity required to operate office equipment, i.e. computers, phones, copy machine/printer
  • Ability to carry, handle and reach for objects
  • Ability to lift and pull up to 15 pounds


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