Quality Assurance Specialist
4 weeks ago
REQUIRED COMPETENCIES:
Knowledge, Skills, and Abilities:
• Working experience of deviation investigations utilizing root cause analysis tools.
• Working experience in the CAPA process and ability to identify and verify effectiveness.
• Technical writing skills and ability to collaborate effectively in cross functional teams.
• Proven ability to accurately and completely understand, follow, interpret, apply Global Regulatory
and cGMP requirements.
• Ability to support health authority inspections.
• Knowledge of data trending and tracking, including use of statistical analysis software a plus.
• Demonstrate advanced problem-solving ability / mentality, technical adeptness and logical thinking.
• Ability to set priorities, manage timelines and effectively react/manage changing priorities.
• Ability to work with management (global and site) and support corporate and departmental goals.
• Ability to communicate honestly, transparently and effectively with peers, department management
and cross functional peers.
• Ability to utilize electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory
Management system) or Infinity.
• Hands on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality
Control.
Education and Experience:
• Requires a Bachelors Degree in science or engineering, preferably
in Biochemistry, life sciences or related engineering discipline (advanced
degree preferred).
• Minimum 1 year of relevant work experience, preferably in a health
authority regulated environment.
• Previous experience working in a biopharmaceutical manufacturing
facility is preferred (CAR T a plus).
DUTIES AND RESPONSIBILITIES:
• Conduct thorough investigations (Environmental Monitoring, deviations, etc.) utilizing root
cause analysis tools.
• Lead investigations and cross functional investigation teams, and close reports in a timely
manner
• Perform GEMBA walks with stakeholders to better understand process steps and evaluate
Root Cause Analysis.
• Work with functional teams to propose effective CAPAs, develop CAPA plans and assure
CAPA effectiveness.
• Assess potential impact and risk to product or process associated changes may have upon
change implementation and develop an appropriate mitigation strategy.
• May Initiate change control documentation
• Identify functional area SMEs to perform impact assessments as part of the change
management process.
• Ensure all investigations are completed in a timely manner. Notify stakeholders of any
delays in a timely manner.
• Provide technical support for manufacturing investigations / CAPAs / change controls as
needed.
• Support deviation investigation defense during audits and site inspections related inquiries.
• Handle complex issues and solve problems with minimal guidance.
• Serve as author or technical reviewer of departmental procedures as appropriate.
• Employ lean manufacturing / six sigma principles to continuously improve products, processes and
systems.
• Continuously support S12, living the patients first mission and fostering a Right First Time
mindset.
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