QA Associate I/II

The Quality Assurance Associate II performs documentation and review functions associated with manufacturing operations while ensuring compliance with cGMP regulations and Quality Systems.

Responsibilities

• General QA GMP documentation activities to support Manufacturing Operations, as well as Quality Control, Facilities, Validation and Materials Management, that would include, but not be limited to:
• Document formatting and review
• Document attachment issuance, reconciliation and distribution
• QUMAS EDMS document coordination
• Maintenance, scanning and archiving of Quality Assurance documentation
• Assignment of equipment numbers
• Assignment of raw material and product part numbers
• Label generation
• Writing/revising SOPs and reports
• Maintaining training documentation and electronic database
• Maintaining Vendor/Material Change Notifications
• SOP, Batch Record and Solution Record review
• Internal auditing

Qualifications

Required Skills:

• Broad knowledge of GMP quality systems, policies and regulations
• Strong written and verbal communication skills
• Proficiency using MS Office Suite (Word, Excel, Access)
• Proficiency using an Electronic Document Management System (QUMAS or equivalent)

Education/Experience:

• BA/BS with 3+ years GMP experience or AS/ABA/ABS with 5+ years GMP experience