Sr. Staff QA Operations Specialist

Who we are: 

Maravai LifeSciences translates extraordinary science into everyday miracles, helping biotech, biopharma, and life sciences companies everywhere deliver novel vaccines, therapeutics, and diagnostics. We are global leaders in providing products and services within the fields of nucleic acid production and biologics safety testing to many of the world's leading biopharma, vaccine, diagnostics, and cell and gene therapy companies.  

At Maravai, we believe that diverse perspectives are the foundation of innovation. Through an inclusive and equitable culture where every team member is inspired to bring their best selves to work, we cultivate an environment in which we can lead together, providing differentiated value to our customers, and enabling the miracles of science. For over 35 years, Maravai’s portfolio companies have served as a catalyst for innovative, lifesaving technology for humanity. Pioneering nucleotide research since its inception, we are now leading the way in the rapidly expanding mRNA market. 

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