Our client, a biotechnology company, has an immediate opening for a QA Specialist.

Responsibilities:

• Develop and execute software validations for software packages that are currently used in the Quality System. Assess FDA 21CFR Part 11 compliance as part of these validations
• Support electronic document management system (Arena) and ERP (NetSuite) integration project for Bill of Materials alignment
• Assist QA Manager in executing organizational and process improvements to the RMA (Return Materials) system
• Assist with Document and Manufacturing Batch Record Reviews as required

Requirements:

• Bachelor’s degree in a related technical field
• 2-5 years of relevant experience
• Competency in 21 CFR Part 820, ISO 13485, and ISO 14971 with experience working within a compliant Quality Management System in regulated industry (Medical Device, Pharmaceutical, etc.) supporting a manufacturing/production site
• Strong comprehension of GDP (Good Documentation Practices) and experience in Document Control practices
• Prior experience with web/cloud-based PLM/QMS platforms, Arena PLM preferred
• Awareness and familiarity with ERP and PLM system architecture and manufacturing documentation (e.g., item/part, BOM, MPN, etc.) with regular usage in prior roles
• Prior experience partnering with cross functional teams including R&D, Manufacturing, Quality, IT, and R&D Software in executing software verification and validation strategies, test scripts, and traceability to requirements
• Prior experience writing and executing protocols/reports for verifications/validations and risk assessments for software used to support the Quality Management System (QMS)
• Effective organizational and time management skills and the ability to work towards multiple priorities while delivering quality outcomes