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 York. This 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.