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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

Qualifications:

+ Bachelors degree preferred

+ One year of experience in a manufacturing or facility environment, though those with less experience but a strong willingness to learn will also be considered.

+ Technical mindset, capable of understanding how equipment works and absorbing process knowledge, even if they haven’t worked in a scientific or pharmaceutical setting.

+ Experience with mechanical systems, such as working with cars, is seen as a plus.

+ A positive, team-oriented attitude and the ability to take instruction are essential.

+ GMP knowledge is preferred

+ 11:30 AM to 8:00 PM.

+ Future/pre-ship shift: 3:00 PM to 11:30 PM.

+ Flexibility needed: Occasionally, workers may need to come in earlier (e.g., 6:30 AM to 3:00 PM), especially when coordination is required across team members.

+ Candidates must be open to occasional schedule adjustments.

Quality Consulting Group, LLC is an equal opportunity employer, and 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.

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