Senior QA Operations Specialist

Role Summary

Senior QA Operations Specialist to join the QA Operations team. Lead the maintenance and continuous improvement of the Quality Management System, including review and approval of deviations, NCRs, CAPAs, supplier management, change controls, and controlled documentation management. Provide review and approval for products and new product development documentation. Track and report on quality metrics and ensure compliance with applicable standards and regulations including ISO 9001:2015.

Responsibilities

• Responsible for reviewing and approving Quality Events (e.g. deviations, NCRs, CAPAs, and complaints) to ensure appropriate investigations are completed timely
• Ensures change control of materials, equipment, processes, procedures including appropriate documentation
• Maintains the control of documents and records
• Provides oversight for training program and conduct quality related training
• Conducts quality investigations to assess root cause, corrections, corrective actions, preventive actions, and monitor effectiveness. Use of quality tools, such as 5-Why's, FMEA's, DMAIC, Cause and Effect Diagrams, Process Mapping, etc.
• Leads cross-functional teams in risk identification and mitigation activities
• Reviews and approves product documentation for disposition of finished goods
• Compiles, maintains, reports, and presents quality metrics during site Quality Management Reviews to ensure visibility of QMS health, including creating trending graphs for weekly, monthly, and quarterly reports
• Leads the audit program, including conducting internal audits and hosting external or third party quality audits (e.g. customers, ISO, etc.)
• Ensures compliance with all in-house or external specifications to standards such as ISO or customer requirements
• Works with various functions, including Manufacturing, QC, R&D, commercial, customer service, technical support, facilities, IT, etc. to continuously improve the Quality Management System
• Supports supplier quality by maintaining the approved supplier list, administering supplier surveys, quality agreements, approved supplier list, and performing critical supplier audits as needed
• Leads quality improvement projects
• Identifies quality issues/ discrepancies and effectively resolves these within the organization
• Perform other functions and duties as required

Qualifications

• Minimum, Bachelor's Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.)
• Quality professional with a minimum of 5 years relevant experience in a life science industry
• Requires knowledge of ISO 9001 standards (or ISO 13485)
• Strong and effective verbal and written communication skills
• Strong interpersonal, teamwork and customer interfacing skills
• Strong problem-solving skills and analytical skills applied to investigations
• Self-motivated and able to organize and prioritize multiple tasks
• Ability to identify quality issues/discrepancies and effectively resolve discrepancies within the organization
• Proficient in Microsoft Office
• Experience with NetSuite ERP and MasterControl is a plus

Skills

• Quality Management System (QMS) oversight
• Investigations and root cause analysis
• Change control and document management
• Quality metrics and reporting
• Auditing (internal and external)
• Regulatory compliance (ISO 9001/13485)
• Cross-functional collaboration

Education

• Bachelor's Degree in a scientific discipline (Chemistry, Biology, Bioengineering, or related)

Additional Requirements

• Experience with NetSuite ERP and MasterControl is a plus