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