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QA - Compliance Investigator

Scope of Position

This role is responsible for conducting investigations and preparing investigation reports for review by customers and health authorities.


  • Coordinates investigation team meetings and activities to facilitate the timely closure of investigations.
  • Coordinates Improvement initiatives monitors the progress of deliverables and provides support.
  • Facilitates QA support and works closely with other functional units including but not limited to, Manufacturing, Validation, Facilities Engineering, Pre-Clinical, Analytical Development, Quality Control, and Global Compliance for designated projects and activities.
  • Interface with clients and Health Authority representatives during investigations and CAPA discussions
  • Prepares and routes investigation reports in TrackWise.

Skills & Technical Expertise:
  • Proficient in TrackWise
  • In-depth knowledge of Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, the USP, ICH Guidelines, and industry best practices. EU GMPs a plus.
  • Knowledgeable and/or exposure to GMP operations, quality system management and quality control testing, etc. especially in the manufacturing of sterile solutions and solid oral dose products
  • Ability to quickly learn new and novel processes supporting new quality projects
  • Ability to self-direct, and adapt to changing priorities
  • Excellent communication and interpersonal skills required
  • Strong attention to detail and organization skills required
  • Proven technical writing and editing skills
  • Root Cause Analysis skills
  • Creative individual with excellent problem-solving and troubleshooting skills
  • Requires the ability to produce results in a fast-paced environment
  • Leadership capabilities
  • Project management capabilities
  • Facilitator training and capabilities
  • Special Skills – influencing, interpersonal, ability to stand alone and dealing with ambiguity
  • Proficiency with electronic management systems (such as Master Control and TrackWise)
  • Experience with MS Office applications and Adobe Acrobat
  • Work independently under general supervision to meet company goals
  • Experience leading cross-functional teams


  • B.S. in a Life Sciences discipline– OR – M.S. in a Life Sciences discipline
  • 5+ years of relevant experience within the life sciences industry, preferably CDMO Manufacturing of pharmaceuticals, performing within a Quality Assurance role