Manufacturing Equipment Investigator

4 days ago


Lakewood, New Jersey, United States GQR Full time
Job Title: Deviations Investigator

Job Summary:

The Deviations Investigator will serve as a primary investigator for the Operations Group to ensure timely and accurate completion of high-quality manufacturing investigations and implementation of subsequent corrective actions.

Key Responsibilities:

  • Own, lead, and support prompt, thorough, and well-written investigations assuring that root cause evaluations are performed in compliance with cGMPs and associated SOPs.
  • Utilize technical writing strategies to ensure content is clear, concise, and complete.
  • Drives investigations to timely closure through collaborative efforts with Operations, Quality Assurance, Engineering, and other functional areas, as needed.
  • As needed, utilize investigational RCPS tools like 6M, Fishbone, and 5 Why's to deliver thorough investigations.
  • Observe activities on the manufacturing floor and engage with Process Owners to gain the process knowledge needed to deliver technically sound investigations.
  • Work with the area owners to identify the most probable root cause(s) and determine appropriate preventive and corrective actions.
  • Discuss investigations as required with regulatory agencies, quality assurance, or clients, as required

Qualifications:

Bachelor's degree in Science/Engineering with a minimum of 3 years of relevant experience in the pharmaceutical industry or additional education in project or documented investigational course work may be substituted for experience on a per-year basis.



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