Quality Assurance Specialist

4 weeks ago


Summit, United States Crox Consulting Inc Full time

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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