JT611 - 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 :

• 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 :

Good knowledge of GMP and the ability to apply regulatory expectations.

Working shift :