Quality Assurance Associate

Direct message the job poster from Belcan

Keyword's: #Sanford jobs; #Assurance Associate jobs.

Start Date:

Immediate

Job Description:

• Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance with local and global quality standards, regulatory requirements, and industry guidance.
• Provide QA review and approval for commissioning/qualification/validation documents.
• Provide QA review and approval of qualification and validation deviations and discrepancies and support investigation and corrective actions.
• Author, review and approved controlled documents for the Quality organization including SOPs, specifications, protocols, and reports.

• B.S. degree in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study and 3-5+ years of experience or M.S. degree and 1-3+ years of experience in a QA function in a biologics manufacturing facility
• Experience with qualification/validation of process equipment, analytical instruments, clean utilities, automation, sterile filling, and clean facilities.
• Strong understanding of FDA, EMA, local regulations and guidelines, ICH guidelines, and industry best practices.
• Successful history working in a fast-paced team environment, meeting deadlines, and prioritization of work from multiple projects
• Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others
• Excellent problem-solving skills and experience with root cause investigations and CAPA determination
• Off hours coverage and flexibility may be required

Mid-Senior level

Contract

• Quality Assurance
• IT Services and IT Consulting

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