Plasma Center Quality Assurance Specialist

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Company: Biotest Pharmaceuticals
Location: Pembroke Pines, FL
Date Posted: March 26, 2015
Source: Biotest Pharmaceuticals
Plasma Center Quality Assurance Specialist

Tracking Code
1539
Job Description

The Plasma Center Quality Assurance Specialist provides quality oversight to Plasma Center operations to ensure high quality and compliance with plasma related regulatory requirements and SOPs.  Writes, revises and processes cGMP documents such as:  Standard Operations Procedures (SOPs), Forms and Batch Records. Participates in Center audit processes. Maintain all required QA Quality Systems and Plasma Center Operations SOPs, and forms in support of the Biotest Pharmaceuticals Corporation Plasma Centers and Quality Assurance Department. Performs internal Center audits to ensure all SOPs are being followed correctly. Assists in all center audit processes, including internal, external customer or Regulatory agency audits. Make appropriate recommendations to Center Management for quality improvements.

The Plasma Center Quality Assurance Specialist writes, processes, and reviews SOPs, Investigational Reports, and other controlled documents. Assists in writing responses to audit findings as necessary. Understands processes such as  QA Quality Systems  such as Deviations, CAPAs, Change Controls, and OOSs. Coordinates projects as assigned by management such as developing new procedures. Assist with new employee and on-going quality related training, as needed, as required.

Required Skills

A Bachelor s Degree required with a minimum of 1-3 years experience in pharmaceutical or biotechnology industry or other related industry.

Required Experience

 Must have knowledge of scientific, medical and regulatory terms.  Ability to use personal computer and software including word processing, spreadsheet and database. Good organizational skills. Mathematical skills including the use of calculations involving fractions, decimals and percentages required.  Must be flexible and available as needed during Center hours and days of operation.

 

 

Job Location
Pembroke Pines, Florida, United States
Position Type
Full-Time/Regular

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