Deviation Investigation Specialist

rockville, Maryland
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Type: Contract

Category: Scientific & Clinical

Job ID: 137023

Date Posted: 04/16/2019


Title: Deviation Specialist

Location: Rockville, MD   

Type: 9+ month contract with possible hire 

Schedule: 9AM-5PM (overtime as needed)

Start Date: Immediate 
 

Innovative Life Sciences Company is currently hiring for a Deviation Specialist to manage and resolve noncomformities relating to manufacturing, technical operations, and quality control. 

Responsibilities: 

  • Ensure deviations, CAPAs, and CCs are timely addressed and closed 
  • Work closely with department subject matter experts to obtain pertinent information necessary to write/close deviations 
  • Provide expertise on necessary preventative measures and ensure deviation metrics are in a controlled state 
  • Act as SME for defending relevant deviations in GMP audits (internal and external).   
  • Lead and coordinate efforts for continuous improvement in deviation reduction and manufacturing operations for the site.  
  • Author and resolve Deviations, Change Controls, CAPAs and additional documents to support production needs and meet product release requirements.
  • Utilize root cause analysis tools and work cross functionally to implement effective CAPAs.
  • Interview personnel involved to determine true root cause
  • Write CAPAs & CCs to meet production release requirements, support continuous improvement efforts and operational optimization. 
  • Write, review, revise and/or prepare documents (BPRs, RPTs, SOPs, SWIs, etc.) in accordance with cGMPs and regulatory guidelines. 
  • Compile and report performance metrics for quality systems.

Requirements:

  • Bachelor's Degree in Science
  • 4+ years of technical writing experience, writing deviations and CAPAs in the pharmaceutical/biotech industry 
  • Experience with FDA audit ready initiatives 
  • Effectively and expertly write technical deviations relating to manufacturing process and review documents with thorough understanding of the biopharmaceutical manufacturing process, GMPs, CAPAs and regulatory guidelines
  • Working knowledge of root cause analysis tools and continuous improvement techniques 
  • Ability to put complex thoughts and issues into writing in such a manner that an educated, but uninformed reader can understand and make decisions based on the written investigation report 

For immediate consideration please send resumes to Gina at gscaccio@jouleinc.com 

   


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