JT611 - MANUFACTURING PROCESS TECHNICIAN - NS bei Quality Consulting Group

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: 

• Responsible for loading materials into machines.
• Schedule manufacturing operations.
• Perform initial review of manufacturing procedures and batch records.
• Train Manufacturing Operators and Associate Manufacturing staff on process theory.
• Draft and revise complex documents (e.g., Manufacturing Procedures, SOPs, technical reports, validation documents, investigation reports).
• Audit critical manufacturing records.
• Propose corrective actions for quality incidents.
• Assist in and plan improvement implementations related to routine functions.
• Collaborate with other departments to implement planned improvements.
• Identify and propose solutions to complex problems.
• Perform data analysis (e.g., SPC, CPV) on critical process parameters.
• Lead equipment and process operations.
• May assist with recruiting efforts.
• May supervise staff.
• May perform system owner responsibilities (e.g., for process or documentation).
• May collaborate with Process Development.
• When assigned to assist the Process Owner under supervision of a Manufacturing.
• Support the generation and review of manufacturing procedures and related documentation.
• Troubleshoot processes and assess performance through process monitoring.
• Participate in the NC/CAPA process by performing process assessments, contributing to investigations, defining/implementing CAPAs, and reporting on incident trends.
• Assist in the generation, review, and execution of process validation protocols.
• Support new product introductions and product lifecycle activities.
• Initiate and implement Level 1 and Level 2 Change Control records.

Qualifications:

• High school/GED and 1 year of work or military experience OR Associate degree
• GMP experience is preferred but not required.
• Basic computer proficiency is preferred but not required.
• Mechanical aptitude and technical expertise.
• Understanding of equipment and manufacturing processes.
• Good knowledge of GMP and the ability to apply regulatory expectations.
• Ability to stand for long periods and lift up to 35 lbs.
• Strong possibility of conversion to full-time for the right candidate.
• Available to work overtime.
• Working shift: 2nd shift (Monday–Friday, 2:30pm to 11:00pm) for the first four months.  
  • Will transition to evening shift (Mon–Thurs, 3:30pm to 2:00am)

Jetzt bewerben