Biotech QA Specialist
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Job Location:
Morrisville, NC - USA
Hourly Salary:
$ 37 - 38
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
QA Specialist (Biotech) needs 3 years of experience in the biotech/pharmaceutical industry within research and development or commercial organizations.
QA Specialist (Biotech) requires:
o Pharma Biotech industry
o Veeva
o cGMP manufacturing environment
o FDA
o Kneat
o Slinshot
o SAP
o Blue mountain RAM
o Knowledge of manufacturing batch record review and/or analytical analyses for the biotech/pharmaceutical
o Degree in Chemistry biological or other
QA Specialist (Biotech) duties:
o Responsible for performing inspection and disposition of raw materials and components by:
o Supporting incoming material release activities within the ERP system ensuring compliance with applicable regulations and internal procedures.
o Get Certificates of Analysis (CoA) Certificates of Compliance (CoC) and other required documentation from vendors in alignment with the Master Specification
o Conduct thorough reviews of logbooks and Work Orders across Manufacturing Engineering Quality and Warehouse departments to ensure entries are complete accurate and compliant with company policies and procedures.
o Responsible for providing QA review/approval of the completed Manufacturing batch records in a timely manner and ensuring that the entries adhere to the company policies and procedures.
Key Skills
- Invoicing
- Information Technology Sales
- IT Support
- Audio Visual
- Database Administration
