Quality Assurance (QA) Associate II
Provide floor support for GMP activities
Monitor for GMP compliance of all in-process activities during GMP processing
Perform AQL particle inspection of in process product vials prior to packaging
Gown qualified for entry into controlled manufacturing grade A, B, C and D areas to perform quality functions as assigned
Perform real time review of executed Batch Documentation and prepare for eventual disposition by QA management
Triage manufacturing deviations for evaluation by QA management
Organize documentation for Batch History Files
Assist with regulatory inspections and partner audits
Perform initial review of straight forward deviations and assign basic investigations as needed, assist in closure
Assist in timely completion of Corrective and Preventive Actions (CAPAs)
Other duties as assigned
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job requires weekend, holiday and off shift work hours.
Source: Job Diva – Job Listing