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 responsiblefor 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 qualityrelated matters for both internal and external customers.
• Represent GMP QA Operations in crossfunctional 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.
• Crosstrain 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 costofgoods 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 Bachelors 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 nonconformance OOS CAPA etc.
  • Use of quality tools such as 5Whys FMEAs 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
• Selfmotivated 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

Theanticipated salary range for this position is $155000 $165000 In addition highly competitive longterm 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 candidates skills experience and other qualifications as well as the location of the role.

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