Quality Assurance Specialist

Support the planning and coordination of all aspects of quality assurance activities with various levels of risk and complexity within a variety of scopes at the site level. Responsible for requests for quality support from the site and communicates policies and procedures. Act as a quality assurance customer contact for the site.

• Assists with the maintenance and continuous improvement of the overall quality system, including management review, CAPA management, internal quality audits, quality self-assessments, change control, document control, and standard operating procedures/work instructions.
• Support ISO registration - as applicable - and other compliance activities.
• Assist management in analyzing information and product specifications to determine regulatory compliance to products handled and services performed at site.
• Provide support on key regulatory, customer and 3rd party audits.
• Track, monitor, and report quality assurance metrics for the site.
• Monitor the training and development of site associates to ensure compliance to processes and regulations
• Be a customer point of contact for QA related issues/initiatives as needed.
• Partner with QA management to develop, distribute and maintain regular management reports.
• Read and interpret technical documents and regulations including quality agreements and contracts.
• Meet regulatory requirements relevant to their operations on a daily basis
• Ensure customer service and business standards requirements are met daily
• Plan, conduct, and act upon inspection processes- Gemba; Standards Confirmation etc. on a daily basis

Bachelor Degree, preferred. Some knowledge of QA, preferred. People management experience, preferred. Sufficient computer application experience. Strong written and verbal communication. Data analysis experience. Training and facilitation skills.

Our Organization is an equal opportunity employer.