JT995 - MANUFACTURING PROCESS TECHNICIAN

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. 
• 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 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 Specialist or Senior Manufacturing Specialist:
• 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 experience
• Mechanical aptitude and technical expertise
• Understanding of equipment and manufacturing processes
• Proficiency in statistical and mathematical analysis
• Good knowledge of GMP and the ability to apply regulatory expectations
• Understanding of analytical methods relevant to the manufacturing environment
• Familiarity with specific manufacturing systems or equipment
• Basic project management capabilities
• Prior experience in GMP environments or basic computer proficiency is preferred 
• Must be proficient in Associate Manufacturing functions and may perform those duties as well
• PPE is provided onsite, and candidates must be comfortable working in a fast-paced, physically active environment
• Day shift (Monday–Friday, 9:00 AM to 5:30 PM) and is expected to transition to a second shift schedule after approximately four months, with shift differential applied
• After 4 months able to transition to evening shift (Mon–Thurs, 3:00 PM – 1:30 AM or 3:00 PM – 11:30 PM depending on business need)
• CANDIDATES MUST BE WILLING TO TRANSFER TO THE SECOND OR NIGHT SHIFT