Heather V. Email & Phone Number

Salt Lake City, Utah, United States

Execute internal and external audit processes to ensure regulatory compliance and a strong quality system at Nelson LabsAct as the main representative of Nelson Labs during external audits to support current and potential customer’s supplier management processesProvide ongoing mentorship for NLI personnel regarding industry expectations and best practices to assist the company to be “audit ready”Perform internal audits as governed by FDA CFR and ISO regulations, identifying non-conformances and opportunities for improvement based on risk to the company. Provide support to laboratory testing, review logbooks, and participate in other Regulatory Affairs processes as needed.

Pleasant Grove, Utah, United States

Direct oversight of business processes and ensures center compliance with all applicable state, federal, and company-designated regulations. Ensures that Standard Operating Procedures (SOPs) are properly interpreted, implemented quickly, and that the staff is trained promptly and effectively.Independently operates while making risk-based decisions.Oversight of all aspects of internal and external audits including execution. This includes documentation, review of and preparation of the response. Continuously assessing, promoting, and improving the effectiveness of the systems in the center through recognition of trends, investigation of failures in the execution of procedures,direct employee observation and review of center documents. Responsible for the personnel functions of the Quality Staff; including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of all personnel records, management of work schedule and delegation/follow-up of tasks. Develop the staff’s knowledge of their job function and how their performance relates to the end product and patient.Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product.

Taylorsville, Utah, United States