JT004 - MANUFACTURING PROCESS TECHNICIAN NS

Quality Consulting Group, LLC; Ohio; On-site; USD 35,000 - 55,000; Full time

Job summary

Join a forward-thinking company in the pharmaceutical industry as a key player in manufacturing processes. This role offers the opportunity to work with a dedicated team, ensuring compliance with stringent standards while driving continuous improvements. You'll be involved in training staff, drafting essential documentation, and collaborating across departments to enhance operational efficiency. If you're passionate about quality and eager to contribute to impactful projects, this position provides a platform for your skills to shine in a dynamic environment.

Qualifications

• 1-3 years of manufacturing experience in an FDA-regulated environment.
• Strong documentation and communication skills are essential.

Responsibilities

• Perform manufacturing processes and train staff on process theory.
• Draft complex documents and propose corrective actions for quality incidents.

Skills

Manufacturing Processes

Data Analysis

Documentation Skills

Communication Skills

Problem Solving

Knowledge of GMP

Equipment Operation

Education

High School Diploma

Tools

SAP

Job description

Quality Consulting Group Job Description

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

Responsibilities:

• Perform manufacturing processes according to Standard Operating Procedures with minimal supervision.
• Review 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 lifecycle activities.
• Initiate and implement Level 1 and Level 2 Change Control records.
• Manage material loading and movement through SAP.
• Operate equipment and document issues and exceptions.
• Support continuous improvement projects.
• Perform equipment cleaning.

Qualifications:

• High School diploma with relevant experience.
• 1 to 3 years of manufacturing experience, preferably in an FDA-regulated environment.
• Pharma experience is a plus.
• Ability to stand for prolonged periods when necessary.
• Knowledge of Operations/GMP.
• Ability to operate advanced equipment safely.
• Strong documentation and communication skills.
• Available for night shift - 2:30 pm to 11:00 pm, Monday to Friday (schedule may vary).

Quality Consulting Group, LLC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.