Manufacturing Investigation Specialist


Job ID 19-00045

Industry Pharma

Job Type Permanent

Location Amityville, NY

Description

Summary:

By using Root Cause analysis training and process improvement skills, assist operations management in evaluation improve the production, packaging, engineering processes at the Amityville plant by implementing projects that result in prevention and reduction of repeated excursions.
 

Essential Functions:   

  • Using root cause determination techniques, assist the operations teams in and / or perform Deviation, Non-Laboratory OOS, OOS, OOT, field complaint and event excursion root cause determination and effective preventative action implementation.
  • Develop and track operations CAPA plans.
  • Evaluate preventative maintenance requirements and work orders for critical equipment to determine effectiveness of PM and potential predictive maintenance schedules.
  • Evaluate filling, packaging and compounding operations for effective and efficient operation.
  • Training of operations management, supervision personnel in performance of effective investigations.


Qualifications

Education & Experience:

  • Bachelor of Science in a Quality / Process related field. 
  • Certified in Six Sigma (minimum of a Green belt, Black belt preferred) or a recognized troubleshooting / root cause analysis program.
  • Minimum of 5 years of root cause analysis experience in a manufacturing, packaging, engineering and distribution environment, preferably pharmaceutical or FDA regulated operation.

Mental Requirements include:

  • Ability to hear accurately the spoken word with moderate office noise or plant noise
  • Ability to apply deductive reasoning and understand complicated issues
  • Ability to receive instructions and follow work rules and company policies
  • Ability to follow safety and security practices
  • Ability to meet deadlines and effectively deal with office stress
  • Ability to accurately communicate ideas, facts, and technical information
  • Maintain confidentiality of certain information

Candidate Details:

  • 5+ to 7 years' experience
  • Seniority Level - Associate
  • Management Experience Required - No
  • Minimum Education - Bachelor's Degree
  • Willingness to Travel - Occasionally