QA Operations Specialist

Role Summary

Staff QA Operations Specialist within Quality Assurance. You will be responsible for activities within the Quality Operations function, including serving as a client liaison, leading project improvement initiatives, and reviewing and approving quality events (e.g., deviations, nonconformances). You will act as a key quality point of contact for internal and external customers and ensure compliance with company policies and procedures, as well as applicable domestic and international standards and regulations.

• Lead and oversee Quality Operations projects to ensure company quality objectives are met.
• Drive and execute quality initiative that align with quality mission, vision, and goal.
• Coach and train internal and external department personnel on maintaining the highest standards of quality and compliance; champion the promotion of a strong Quality Culture.
• Act as a primary point of contact for quality-related matters for both internal and external customers.
• Represent QA Operations in cross-functional teams in risk identification and mitigation activities during risk management process.
• Lead/Support quality investigations including deviations, nonconformances, and laboratory investigations, ensuring a thorough root cause analysis and effective corrective/preventive actions has been defined.
• Cross-train to perform QA Operation functions such as review, evaluate, and approve manufacturing room releases, production batch records, product releases, support raw material activities, etc.
• Present QA Operation processes in support of external quality audits (eg., customers, ISO, etc)
• Develop, maintain, and communicate quality metrics to ensure visibility of QMS health.
• Identify opportunities to improve quality, reduce cycle time, lower cost-of-goods, and increase operational efficiency.
• Work with various functions, including Manufacturing, QC, T&D, commercial, customer service, technical support, facilities, IT, etc. to develop, implement, and continuously improve the Quality Management System.
• Perform other functions and duties as required.

• Bachelor’s Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.)

• Quality/GMP professional with a minimum of 7 years relevant experience in a life science industry
• Requires knowledge of ISO 9001 (or ISO 13485) standards and cGMP regulations (e.g., 21 CFR 210/211)
• Familiar with cleanroom operations (operating in a cleanroom, EM monitoring, validation, etc.) is preferred but not required.
• Understand Quality Event processes (deviation, non-conformance, OOS, CAPA, etc.) and use of quality tools, such as 5-Why’s, FMEA’s, DMAIC, Cause and Effect Diagrams, Process Mapping
• Experience in supporting inspection readiness activities resulting in successful inspections

• Strong and effective verbal and written communication 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