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:        

• Hands-on operations: set-up, cleaning, and sanitization of various manufacturing equipment
• Weigh various chemicals
• Interact with automated control systems (Delta V and MES)
• Batch, filter and transfer liquid solutions
• Material coordination and management (warehouse)
• Weighing out 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
• Performing in-process sampling of equipment and operating analytical equipment
• Performing parts washing and sterilization activities
• Maintaining an organized and clean workspace
• Initiating and being involved quality deviation reports, as required
• 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)
• Working around high-pressure systems, occasionally work around/moving heavy equipment with powered industrial vehicles
• Perform routine manufacturing process operations (equipment cleaning, dispensing of raw materials/components, material reconciliation etc.)
• Performs/Facilitates process, area, and equipment inspections and risk assessments as needed. (IC
• Lift and move up to 30 lbs (laptop and peripherals, laboratory materials, raw materials)

Qualifications:

• Bachelors degree preferred
• 3 years' work experience in manufacturing.
• Exposure to a GMP environment
• Ability to focus, understand and follow written cGMP procedures and document according to cGMP requirements via hard copy and electronically
• Ability to identify potential hazards, risks, failure modes, and mitigating actions
• Identify, recommend, and implement improvements related to routine floor operations
• Monitor and troubleshoot critical processes and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports such as deviations
• Applies basic chemistry, biology and mathematical principles for sample analysis and documents testing results
• Experience in Biotech or anything with batch chemicals or chemical processing.
• Night Shift position** Night Shift Schedule as follows: 6:45PM - 6:45AM.- Week 1 is 5 working days Week 2 is 2 working days.
• Candidates must be available to work weekends and holidays.

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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