Investigative Writer (GMP background) – Fresenius Kabi – Grand Island NY, Buffalo Area

POSITION SUMMARY:

Independently responsible for the efficient and thorough investigation of process deviations and customer complaints, determination of root cause, and initiation of corrective/preventative actions designed to adequately address and correct the Quality related deficiencies identified during the investigation process.

Responsible to provide proactive corrections based on noted trends to minimize the potential for repeat incidents that may lead to, or result in, the issuance of Product Discards, Field Actions, or Recalls.

The position requires working with minimal supervision to manage assigned investigations from initiation to completion.

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT:

  • Responsible for ensuring compliance with relevant Standard Operating Procedures, while gathering, analyzing and applying information from internal and external sources in order to perform a risk assessment of the impact each process deviation and complaint has on the product, process, and patient health and safety.
  • As part of each investigation, gathers information from all necessary internal and external sources in order to evaluate the impact of the deviation on previously manufactured products, as well as the risk to future operations.
  • Prepares and analyses manufacturing and laboratory analytical historical data, and uses methodical root-cause analysis tools to determine root causes and effectively communicates the root cause to senior management.
  • The incumbent will need to properly assess the manufacturing or analytical environment, independently conceive, and advise senior management on appropriate corrective/preventative actions designed to mitigate Quality deficiencies identified in the investigative process using industry accepted analytical tools.
  • The individual in the position provides technical expertise to the site to ensure that investigation corrective and preventative actions are complete, thorough, accurate, and timely.
  • Updates and maintains all related enterprise quality management systems in compliance with various governing procedures and policies as they relate to investigations and performs a trend analysis of all incoming complaints.
  • Works independently to comply with procedure-driven guidelines relating to Deviation and complaint investigations and makes decisions that directly affect patient health and safety.
  • Prepares all relevant information necessary for the Annual Product Quality Review.
  • Demonstrates strong technical skills, provides technical assistance to area supervisors or managers to solve complex problems.
  • Ensures that deadlines are maintained and closely monitors the need for extensions to be administered in relation to Subsequent Actions and Investigations in order to maintain compliance in this area.
  • Assists with responding to Audit Observations, and aids in the facilitation of ensuring timely completion to Audit responses commitments as requested.

REQUIREMENTS:

  • BA/BS Degree in science field; Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience.
  • 3-5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices.
  • Good deductive and inductive critical thinking skills.
  • Advanced writing skills.
  • Candidate must possess strong interpersonal, written, and verbal communication skills.
  • Incumbent must be able to interface positively with Regulatory Agencies, vendors, and company departments.
  • Good knowledge of MS Office programs, including Word and Excel.

 

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