Our client is an established pharmaceutical services company servicing businesses around the globe. They are currently seeking a QA Specialist to join their team.
Salary/Hourly Rate: DOE
Position Overview: The successful QA Specialist will work in the QA group of this cGMP lab with primary functions in the area of lab data review and reporting.
Responsibilities for the QA Specialist:
• Perform detailed lab data review to ensure accuracy and completeness of testing documentation
• Ensure compliance of testing with procedures and test methods
• Work with the QC group to correct any errors and omissions in documentation
• Review and approve release Certificates of Analysis
• Assist in performing CAPA and reviewing investigations and Out of Specification data
• Assist with the development of SOPs or other quality documents as needed
• Assist in internal audits of the analytical laboratories and QA systems
• Perform other QA responsibilities as assigned
Requirements for the QA Specialist:
• Lab experience in wet chemistry, HPLC, GC and other standard QC lab skills required
• Experience in USP, BP, EP etc. highly desirable
• QA experience in documentation, CAPA, CoA for raw materials release highly desirable
• Knowledge in OOS review, data review highly preferred
• Good computer and writing skills needed
• Science degree ideally in Chemistry
Benefits: Eligible for Atrium Care Package
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