Investigative Writer in Buffalo at Apple & Associates

Date Posted: 10/1/2018

Job Snapshot

Job Description

Our client is a global manufacturer of life-saving pharmaceutical products, seeking an Investigative Writer to join their Compliance Team in their Buffalo, NY site. The Investigative Writer will be responsible for the investigation of process deviations and customer complaints, conducting root cause analysis and identifying corrective/preventative actions to address and correct Quality deficiencies. The Investigative Writer take a proactive approach to identifying trends in order to minimize incidents that may result in product recalls or discards.

Responsibilities:
  • Ensures compliance with Standard Operating Procedures while gathering and analyzing information from internal and external sources in order to perform risk assessment on process deviations
  • Evaluates the risk of the deviation on previously manufactured product and potential impact for future manufacturing
  • Uses methodical root cause analysis tools to identify root causes and communicate to management
  • Maintains all compliance with governing procedures pertaining to investigations and performs trends of all complaints
  • Provides technical expertise to the site for investigation corrective and preventative actions
Requirements:
  • Bachelor's degree in a science related field or equivalent combination of education and experience
  • 3-5 years of pharmaceutical industry work with emphasis on Good Manufacturing Practices (GMP's)
  • Advanced writing skills a must
  • Strong analytical skills
  • Ability to work with Regulatory agencies, outside vendors as well as internal departments
  • Proficiency in Microsoft Office
  • Must have experience with Root Cause Analysis, Annual Product Quality Review and Field Alerts

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