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Job: Quality Specialist, Cygnus Technologies, Southport, NC
Southport, NC 28461 United States
Cygnus Technologies Inc. (part of Maravai Life Sciences) is focused on supplying highly specialized analytical products to the pharmaceutical and biotechnology industry for use in process development and quality control. As recognized experts in bioprocess contaminant testing for analysis such as host cell proteins, Cygnus offers a broad menu of well-validated, robust generic kits and immunoassay reagents. Cygnus also offers custom product-specific development of antibodies and assays for companies who want to outsource these highly specialized technologies to the experts. We have an excellent opportunity for a Quality Assurance Specialist to support our current customer base and drive the growth of our business.
The Quality Assurance Specialist is responsible for implementation, maintenance, and continuous improvement of the Quality Management System, including CAPA, non-conformances, deviations, product approval, and supplier management, etc. This role ensures compliance with applicable domestic and international standards and regulations.
PRIMARY RESPONSIBILITIES AND DUTIES:
• Develop and manage the non-conformance, deviation, complaint, and CAPA systems. Work with investigation owners to assess root cause, corrective actions, preventative actions, and effectiveness
• Provide training in quality procedures and ensure maintenance of training records
• Review and approve manufacturing records, labels, and testing data for product and incoming material disposition
• Leads and/or participate in internal audits, external audits, and supplier questionnaires
• Manage supplier quality management, including supplier qualification, quality agreements, and maintenance of the approved vendor list
• Assist with document and record control functions as needed
• Report periodic quality system metrics and perform trend analysis. Make recommendations to functional owners and partner with the operations team on solutions
• Lead quality improvement projects, including planning, communicating, developing action plans, and providing regular project updates
• Assure compliance with all company and external specifications and applicable standards.
• Monitor equipment maintenance and calibration
• Perform other QA functions and duties as required
• BS Degree in scientific discipline
EXPERIENCE AND QUALIFICATIONS:
• Quality professional with a minimum of 3 years in a quality role in a life science industry.
• Requires knowledge of ISO 9001, 21 CFR 820, or 21 CFR 211.
• Strong verbal and written communication skills.
• Strong interpersonal skills.
• Strong problem solving skills and attention to detail.
• Self-motivated and able to organize and prioritize multiple tasks.
• Identify quality issues/discrepancies and effectively resolve discrepancies within the organization. Job Type: Full-time
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