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- Posted 02 March 2023
- LocationNew York
- Job type Contract
- Contact NameTaylor Whelpton
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.
- 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.
- Bachelor’s degree in Life Sciences, Engineering or related fields.
- 2+ Years of experience in a Quality Assurance Specialist position.