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Quality Investigator

Townsend & Associates St. Louis Contractor
Competitive Salary Based on Experience
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Quality Investigator

Responsibilities:
  • Supply qualified investigators, to provide guidance, coaching and coordination for all aspects related to the initiation, tracking, trending and management of all investigations, corrective and preventive actions (CAPA}.
  • Work with the operations leadership team and Quality Assurance to facilitate the consistent and disciplined execution of the investigation system ensuring the completeness and comprehension of the investigations while determining the most probable root cause.
  • Review and analyze CAPA effectiveness through appropriate tracking and trending methods in order to prevent reoccurrence.
  • In charge of daily/weekly reports to management.
  • Investigate, write and close out root cause investigations/CAPAs.
  • Implement necessary follow-up verification checks on investigation Corrective and Preventive Action (CAPA} items closing them out throughout term of project.
  • Coach Company colleagues to facilitate a focused knowledge transfer regarding quality investigations regularly throughout term of project.
  • Review Company's SOPs related to the quality investigational system and assist with improvement/revisions in a timely manner throughout term of project.
  • Attend any investigational related meetings.
  • Daily reports to Company as required.
  • Weekly progress reports will be supplied to Company management outlining all activities, current status and estimated completion dates, unless otherwise directed by Company.
  • Investigate, write and close out all investigations in accordance with company & FDA & GMP standards; throughout the Provider's engagement while adhering to company and cGMP standards within a 30 day time frame.
  • Investigate Root Cause, write and implement CAPAs and interact with necessary departments and people to get the job done.
  • Must respond timely to deliver quality investigations and thorough CAPAs throughout the term of the project.

Quality Investigator

Quality Investigator

W2 ONLY!!! NO CORP TO CORP!

Qualifications:
  • Bachelor's degree is preferred.
  • GMP Pharma experience is critical.
  • Knowledge of aseptic processing in critical.
  • 8 years of experience performing investigations in a Pharma environment is critical.
  • 2+ years of experience doing investigations performed in an aseptic environment and in a Quality Investigation role is required.
  • Experience w/ Aseptic Techniques, Manufacturing, GMP and FDA.
  • Knowledge of the following areas are critical:
    • Root Cause Analysis performed in an aseptic environment.
    • Investigations performed in an aseptic environment.
    • cGMP's both US and other countries.
    • Manufacturing Environment, Processes and Intradepartmental Linkages.
    • Demonstrated Problem Solving Skills.
    • Experience writing CAPAs in a Pharma environment.
    • Ability to demonstrate analytical thinking skills.
    • Root Cause Analysis performed in an aseptic environment experience.
  • cGMP's both US and other countries experience.
  • Manufacturing Environment, Processes and Intradepartmental Linkages experience.
  • Additional biology or microbiology experience is a plus.
  • Environmental compliance is a plus.
  • FDA Compliance and GMP experience.

Quality Investigator

Recommended skills

Certified Global Meeting Planner
Good Manufacturing Practices
Coordinating
Corrective And Preventive Action (Capa)
Manufacturing
Operations
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Job ID: 17-02115

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