Pay $76-$81 per hour On-site Role 1 year extendable contract Medical, Dental, Vision, 401k The Specialist, QA Validation will be primarily responsible for the implementation, execution and assessment of quality systems, procedures, and records to support compliant GMP operations. This position works closely with Validation, Engineering, Manufacturing, Quality Control, Facilities, and Automation. Responsibilities and Accountabilities: 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. Qualifications: 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
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