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.
- Review 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 improvements related to routine functions.
- Collaborate with other departments to implement improvements.
- Identify and propose solutions to complex problems.
- Perform data analysis (e.g., SPC, CPV) on critical process parameters.
- Lead equipment and process operations.
- Support generation and review of manufacturing procedures and documentation.
- Troubleshoot processes and monitor performance.
- Participate in NC/CAPA processes, including investigations and trend reporting.
- Assist in process validation protocols and new product introductions.
- Initiate and implement Change Control records.
Qualifications:
- High school/GED and 1 year of work experience.
- Mechanical aptitude and technical expertise.
- Understanding of equipment, processes, and analytical methods.
- Proficiency in statistical and mathematical analysis.
- Knowledge of GMP and regulatory expectations.
- Familiarity with manufacturing systems or equipment.
- Basic project management skills.
- Experience in GMP environments and computer proficiency preferred.
- Willingness to work in a fast-paced, physically active environment.
- Availability for day shift (Monday–Friday, 9:00 AM to 5:30 PM) and transition to evening shift after four months (Monday–Thursday, 3:00 PM – 1:30 AM or 11:30 PM).
Quality Consulting Group, LLC is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, veteran status, disability, or other protected characteristics.