QC Lab Investigations Specialist


Job ID 19-00044

Industry Pharma

Job Type Permanent

Location Amityville, NY

Description

Summary:
Reviews, coordinates, and assists to ensure non-conformances are adequately investigated for determination of root cause and product impact per FDA regulations. Using Root Cause analysis training, manage and coordinate quality control laboratory investigations (out-of-specification, out-of-trend, non-conformance, and deviation). Ensures corrective and preventive actions (CAPA) are identified and implemented to prevent/reduce reoccurrence.
 

Essential Functions:  

  • Author, track monitor, facilitate closure, and QA review of investigations, out of specification (OOS) and out of trend (OOT) reports for compliance to FDA regulations and other guides/guidelines.
  • Using root cause determination techniques, perform Non-Conformance, Deviation, OOS, and OOT investigations to determine the root cause and effective corrective / preventive action (CAPA) implementation to prevent recurrence of the event.
  • Experience performing, reviewing and issues associated with Quality Control laboratory chemical and physical testing.
  • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines.
  • Provide cGMP guidance to functional groups such that all non-conformances are closed within defined timeframes and product release dates.
  • Work with cross-functional teams to develop and track CAPA plans.
  • Work with quality control and operations personnel in performance of effective investigations.
  • Evaluate trends of investigations and CAPA's to identify major areas of opportunity for improvement.
  • Assist during regulatory inspections or other audits as required
  • Provide training to function areas on compliance issues


Qualifications

Education & Experience:

  • Bachelor of Science in Chemistry or equivalent experience. 
  • 2 years of root cause analysis experience related to quality control non-conformances, preferably pharmaceutical of FDA regulated laboratory and prior knowledge of Track Wise system is a plus.
  • Minimum of 5 years' experience in Quality Systems relating to deviations, investigations, out of specifications (OOS), non-lab out of specifications, corrective and preventive actions (CAPA), and product complaints.  
  • In addition, experience in performing cGMP related training preferred
     

Mental Requirements include:

  • 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.
  • Must exhibit strong organizational, communication, interpersonal skills and attention to detail.
  • 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