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Senior QA Specialist

Research Triangle Park Metro Area, NC

Posted: 10/03/2019 Job Type: Scientific Job Number: JN -102019-25735 Region: Research Triangle Park Metro Area

Job Description

Duties:

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


Skills:

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)


Education:

Bachelors or Master s Degree, in Life or Physical sciences

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