Operations Support Specialist

Johnson & Johnson MedTech

Anasco, Puerto Rico, United States of America
Capa investigations
Capa management
Capa processes
Under the direction of the Operations Manager, conduct and provides technical leadership towards the identification of the causes for non-conformances and process, failures and for the implementation of the remedial, corrective and preventive actions thus assuring process performance and compliance against Site QSR, GMP and ISO requirements for the entire Business Unit manufacturing process

Job Summary

  • Under the direction of the Operations Manager, conduct and provides technical leadership towards the identification of the causes for non-conformances and process, failures and for the implementation of the remedial, corrective and preventive actions thus assuring process performance and compliance against Site QSR, GMP and ISO requirements for the entire Business Unit manufacturing process.
  • Responsible for overseeing the Non Conformance Report (NRs) and Corrective action and preventive action (CAPA) and Audit Observations.
  • Provide guidance to manufacturing supervisors to ensure that effective in-depth investigations are performed.

Matching Summary

Under the direction of the Operations Manager, conduct and provides technical leadership towards the identification of the causes for non-conformances and process, failures and for the implementation of the remedial, corrective and preventive actions thus assuring process performance and compliance against Site QSR, GMP and ISO requirements for the entire Business Unit manufacturing process.

Skills & Requirements

Must-have

  • CAPA Investigations
  • CAPA Management
  • CAPA Processes
  • QSR, GMP, ISO knowledge
  • FDA 21 CFR regulations

Nice-to-have

  • Analytical Reasoning
  • Good Manufacturing Practices (GMP)
  • Lean Manufacturing Principles
  • Problem Management
  • Project Engineering

Key Requirements

  • Bachelors Degree required
  • Minimum of 4 years experience in NC/CAPA & Audits Observations
  • Bilingual (Spanish & English)

Work Rights

Not specified

Tailored Resume

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