QA Associate

Job Description

Job Description

Purpose & Scope :

Provide inter- and intradepartmental support in the preparation and review of documentation related to and including manufacturing processes, equipment, and computer systems that affect GMP- related activities. Review and approval of batch records.

Essential Job Responsibilities :

• Validation / Protocol documentation review and approval
• Laboratory OOS review and approval
• Site Change Control review and approval
• Assist in the investigation, reporting, and resolution of minor deviations
• Provide cGMP Training as required
• Product complaint Investigation
• Preparation of QA metrics
• Preparation of specimen samples of all packaging components and artwork
• Performance of QA line clearances and on-the-floor inspections
• Administration of ZenQMS Training Management System
• Review and approval of executed batch records and all records in support of batch release
• Participation in QA internal audit program
• Represent QA on sitewide project teams

Quantitative Dimensions :

This position has a direct impact on batch processing and release, disposition of materials and components, and approval and disposition of minor level deviations. This position has an indirect impact on the compliance state of APT, interaction with international regulatory agencies, and site wide project support.

Organizational Context :

JOB DESCRIPTION

Qualifications :

Preferred