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:

Under limited supervision, 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 such as MPs, SOPs, technical reports, validation documents, and investigation reports

Audit critical records

Propose corrective actions for Quality incidents

Assist with and plan implementation of routine process improvements

Collaborate with other departments to execute planned improvements

Identify and propose solutions to complex problems

Perform data analysis (e.g., SPC, CPV) on critical process parameters

Serve as a lead for equipment and process operations

Support the generation and review of manufacturing procedures and related documentation

Troubleshoot processes and assess performance through monitoring

Support training activities

Participate in NC CAPA processes by conducting process assessments, joining cross-functional investigations, defining/implementing CAPAs, and reporting on incident trends

Assist in generating, reviewing, and executing process validation protocols

Support new product introductions and product life cycle activities

Initiate and implement Level 1 and Level 2 Change Control records

Material loading and movement through SAP

Operating Equipment and documenting issues and exceptions

Support any continuous Improvement projects

Equipment cleaning

Qualifications:

Bachelors degree preferred or High School diploma with experience

Manufacturing experience, pharma experience, experience working within a regulated environment or with equipment.

Candidates may be needed to stand for prolonged periods when necessary.

Operations/GMP knowledge

Ability to operate Advanced Equipment safely

Documentation and Communication Skills

Night shift - 2:30pm - 11pm - Monday - Friday