Qaulity Investigator

Posted 02 March 2023
LocationNew York
Job type Contract
Contact NameTaylor Whelpton

Job description

Quality Investigator Contractor

Pharmaceutical Manufacturing (cGMP)

12 Month Contract


BioTalent is currently seeking a Quality Investigator to join their quality department in Long Island New YorkThis role carries out all compliance-related duties required to complete investigations and put effective corrective measures in place to support manufacturing operations.


Responsibilities include:


  • Investigating non-conformances and preventing recurrences to help production processes.
  • Creating investigation reports with suggestions for medium- to high-severity non-conformances based on investigation results.
  • Analyze and review data from investigations, and create relevant report findings.
  • Presenting facts and suggestions during group sessions.
  • ·cGMP standards-compliant review of completed batch records and logbooks in support of investigations.
  • Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures
  • Monitoring production processes to acquire vital data in support of investigations and track efficiency of changes
  • Participating in and/or leading cross-functional study teams to get results, support and or author investigations
  • Gathering, trending, and analyzing process related data to drive cbarrionsistency and timeliness
  • Documenting all training
  • Training new employees on investigative processes and techniques
  • Coordinating and/or leading cross-functional meetings with multiple departments.


Experience Required:

  • Bachelor’s degree in Life Sciences, Engineering or related fields.
  • 2+ Years of experience in a Quality Assurance Specialist position.