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