Quality Assurance Associate

Job Responsibilities:

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. Work collaboratively with other site functions to instill a ‘Quality Culture’ by coaching in the application of GMP principles including the underlying rationale of those principles. Author, review and approved controlled documents for the Quality organization and other GMP functional areas including SOPs, specifications, protocols, and reports. Assist in the preparation and hosting of regulatory (e.g. FDA, EMA, DHHS, etc.) inspections as needed. Skills:

Strong knowledge of risk-based approach to qualification and validation activities in a Biotech Quality environment. 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. Advanced computer skills. Off hours coverage and flexibility may be required. Education/Experience:

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