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 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:

• Work in a dynamic production environment at the client's Drug Substance plant supporting development, clinical, and launch activities.
• Under general supervision, employee will perform operations in the Manufacturing area, specifically for Purification processes.
• Operations will be performed according to Standard Operating Procedures (SOPs) while complying with GMP standards in safe manner.
• Hands-on operations: set-up, cleaning, and sanitization of various manufacturing equipment
• Preparing buffers/media per defined manufacturing procedures (MPs) and standard operating procedures (SOPs)
• Following GMP documents (SOPs, MPs) with strict adherence to safety and compliance
• Performing and monitoring critical processes with the ability to perform basic troubleshooting
• Initiating quality deviation reports
• Drafting and revising documents (SOPs, MPs)
• Identifying, recommending, and implementing improvements related to routine functions
• Assisting in the review of documentation for assigned functions (equipment logs, batch records)
• Performing in-process sampling of equipment and operating analytical equipment
• Working around high-pressure systems and work around heavy equipment

Qualifications:

• Bachelor’s degree in a science-related field is preferred, but candidates with relevant manufacturing experience will also be considered. 
• highly adaptable team player who can work in a structured, fast-paced manufacturing environment.
• The ideal candidate has experience with large-scale purification processes, including chromatography, filtration, and pressurized equipment.
• Candidates must be detail-oriented, open to feedback, and able to follow strict GMP documentation procedures.
• Primary Shift: 7:00 AM – 8:00 PM to start
• Rotating Shift: 7:00 AM – 8:00 PM and 7:00 PM – 8:00 AM (6-month rotations)
• Weekend Work: At least one weekend day per shift.
• Holidays: Required.
• Must be able to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs, 3 or 4x12hrs)

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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