JT878 - MANUFACTURING PROCESS TECHNICIAN - NS

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

• Performs manufacturing processes according to Standard Operating Procedures
• Operating high speed packaging equipment
• Must be proficient at Associate Manufacturing and may perform those functions in addition
• Perform initial review of manufacturing procedures/batch records.
• Draft and revise more complex documents (e.g. MPs, SOPs, technical reports, validation documents, investigation reports, etc.)
• Audit critical records.
• Propose corrective action for Quality incidents
• Assist & plan improvement implementation related to routine functions
• Interact with other departments to implement planned improvements
• Identify and propose solutions to complex problems
• Perform data analysis (e.g., SPC, CPV) of critical process parameters
• Lead capacity for equipment/process operations.
• May perform system owner responsibilities (i.e., process, document)
• Supports manufacturing procedures (and other related documentation) generation and review process
• Troubleshoots process and assesses process performance thru process monitoring.
• Supports NC CAPA process by completing process assessments and participating in cross functional investigational teams, defining and implementing CAPAs and reporting incident trending.
• Assists in the generation, review and execution of process validation protocols.
• Supports new product introduction and product life cycle.
• Initiates and Implement Level 1 and Level 2 Change Control records
  

Qualifications: 

• Bachelor’s degree in Life Science and/or Engineering
• 1-3 year of experience in manufacturing preferably in a FDA regulated environment
• Mechanical ability/expertise.
• Understand equipment/processes.
• Technical writing capability
• Ability to interpret and apply GMP concepts.
• Understand analytical methods for manufacturing area
• Basic project management skills
• Shift: 3rd shift from 3:30pm - 2:00 AM (Mon – Thu)
  • Some Fridays are worked and overtime
  • Can expect to need to work OT 2x/month on average