Manufacturing Process Specialist

hace 18 horas


Juncos, Puerto Rico Quality Consulting Group A tiempo completo
Job Description:

At Quality Consulting Group, we are seeking a highly skilled Manufacturing Process Specialist to join our team. As a key member of our organization, you will be responsible for ensuring the efficient and effective execution of manufacturing systems.

Responsibilities:

  • Support the development and implementation of manufacturing/quality systems, including process validation, procedures, training, and new product introductions.
  • Apply process, operational, scientific expertise, and analytical and troubleshooting skills to support manufacturing operations.
  • 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 to ensure alignment with current operations.
  • Ensure all procedures reflect current operations and serve as a document owner.
  • Assess process performance by observation of floor operations and review of performance data.
  • Evaluate, plan, and implement solutions for process improvement opportunities.
  • Assist in generation of training materials and provide training on scientific or technical aspects of the process.
  • Collect process-monitoring data and support the assessment of deviations.
  • Provide support for timely execution of the process monitoring quarterly reports.
  • Ensure that all Non-conformances are triaged within the established goal.
  • Responsible for managing NC/CAPA closure within established goals.
  • Review equipment/system Root Cause Analysis investigations and support trend evaluations.
  • Assist with generation of process validation protocols and reports.
  • Assist with the execution of the process validation.
  • Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
  • Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
  • Assist manufacturing change owner on CCRB packages impacting the process.

Qualifications:

  • Bachelor's degree in Sciences or Engineering.
  • 5 years of Manufacturing Process, Documentation Revision, CAPA's, Change Controls experience.
  • Experience with Veeva, Trackwise, CAPA, Change Control.
  • Detailed technical understanding of bioprocessing unit operations.
  • Skilled in performance of GMP production operations.
  • Regulatory knowledge and interactions.
  • Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.

Company Overview: At Quality Consulting Group, we strive to be a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry. We believe in providing equal opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.



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