Sr. Staff QA Operations Specialist

Your next role as a Miracle Maker 

TriLink Biotechnologies, a Maravai LifeSciences company, is seeking a #MiracleMaker to join our Quality Assurance team as a Senior Staff Quality Assurance Operations Specialist. In this role you will be responsible for activities underneath the GMP Quality Operations function, including client liaison, project improvement initiatives, and approval of quality events (e.g., deviations, nonconformances, etc.).  You will be a quality point of contact for internal and external customers and ensure compliance with company policies and procedures and applicable domestic and international standards and regulations.

How you will make an impact: 

• Lead and oversee GMP 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 the primary point of contact for quality-related matters for both internal and external customers.
• Represent GMP 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 GMP QA Operations and Raw Material functions such as review, evaluate, and approve manufacturing room releases, production batch records, product releases, support raw material activities, etc.
• Present GMP 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 duties, as assigned.

 The skills and experience that you will bring: 

• Minimum, Bachelor’s Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.)
• Quality/GMP professional with a minimum of 10 years relevant experience in a life science industry
• Minimum of 5 years of leadership experience
• Requires knowledge of ISO 9001 (or ISO 13485) standards and cGMP regulations (e.g., 21 CFR 210/211)
• Familiar with cleanroom operations (e.g., operating in a cleanroom, EM monitoring, validation, etc) is preferred but not required.
• Understand Quality Event processes (deviation, non-conformance, OOS, CAPA, etc.)
  • Use of quality tools, such as 5-Why’s, FMEA’s, DMAIC, Cause and Effect Diagrams, Process Mapping, etc
• 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
• Experience in supporting inspection readiness activities resulting in successful inspections

 The anticipated salary range for this position is $155,000- $165,000  In addition, highly competitive long-term incentives in the form of company equity, bonus participation and company sponsored benefits are provided as part of the total compensation package.  The salary offer will depend on multiple factors which may include the successful candidate's skills, experience and other qualifications, as well as the location of the role.  

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