Senior QA Specialist
Research Triangle Park Metro Area, NC
The QA Specialist will provide support related to Supplier Quality. The QA Specialist will draft documentation related to Supplier Quality for review. QA Specialist will also assist the with the tasks associated with monitoring defective supplies.
Prepare drafts for review of change requests, facility approval applications, supplier evaluations, non-conformance reports, etc.
Assist in monitoring defective supplies and third party plasma supplier data
Prepare reports from Plasma Operations Plasma Quality Database for purposes of identifying expiring or expired regulatory certifications for third party plasma suppliers
Assist with Change Control Management System Task Reporting
Maintain various Supplier Quality logs and spreadsheets
Post various documentation to a shared drive or to the company Portal
Print and/or file Supplier Quality documentation
Comply with Site Environmental Health & Safety (EH&S) requirements
Minimum of 10 years work experience, with a minimum of 5 years in a regulated (GMP/ISO/QSR) industry or
Minimum of 5 years in a regulated (GMP/ISO/QSR) industry or minimum 5 years QA experience
Ability to logically evaluate and solve simple or moderate problems on a daily basis
Experience in technical writing
Ability to work in a cross-functional team with excellent interpersonal, communication skills
Working knowledge of MS Word, Excel, PowerPoint, and Adobe Acrobat Pro
Must have good planning and organizing skills, manage time effectively by prioritizing tasks, be flexible with changing priorities, and know when to obtain assistance.
Individual must work in an ethical manner and ensure employees follow company ethics and compliance guidelines
Fluent English (oral and written)
Bachelors or Master s Degree, in Life or Physical sciences