Manufacturing Operations Specialist

hace 15 horas


Juncos, Puerto Rico Pharmalex A tiempo completo

About Us

PharmaLex is a leading consulting company in the Healthcare industry, providing expert services globally. We foster professional growth and development, along with a collaborative work environment that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.

Job Overview

We are seeking an experienced Manufacturing Operations Specialist to support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions.

Main Responsibilities

  • Apply process expertise to support manufacturing operations, ensuring compliance with regulatory requirements.
  • Serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
  • Initiate, revise, and approve manufacturing procedures, ensuring all procedures reflect current operations.
  • Evaluate process performance by observation of floor operations and review of performance data.
  • Provide troubleshooting support and assist in generation of training materials.

Process Monitoring and Control

  • Support establishment of process monitoring parameters and control limits.
  • Collect process-monitoring data and assess deviations.
  • Provide timely execution of process monitoring quarterly reports.

Non-Conformance and CAPA

  • Triage all Non-conformances within established goals.
  • Author investigation reports and execute corrective actions.


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