QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!

We are seeking a C&Q Specialist with expertise in execute qualification activities around an OEM-driven retrofit to an existing GMP manufacturing isolator.

Responsibilities: 

• Prepare and maintain all commissioning documentation.
• Coordinate execution with contractor and vendors.
• Maintain commissioning status reports. 
• Coordinate closure of deficiencies. 
• Participate in project meetings.
• Support turnover to Operations and Maintenance. 
• Maintain commissioning records.
• Provide editable electronic copies of all deliverables. 
• Provide final PDF copies of all approved deliverables. 

• Bachelor Degree in Science or Engineering or related field. 
• Background in pharmaceutical products manufacturing environmental specially in sterile packaging area. 
• Experience in commissioning and qualification. 
• Strong knowledge of cGMPs regulations. 
• Startup and operational readiness experience. 
• More than 5 years of experience in commissioning related projects. 
• Experience in digital validation solutions. 
• Good skills writing validation/commissioning, and technical documentation in English and using MS Office applications.  
• Bilingual (English & Spanish) 

Benefits

What We Offer

• Opportunities for learning, development, and professional growth.
• A collaborative and supportive work environment.
• The opportunity to work with industry-leading clients on impactful projects.

Your information will be kept confidential according to EEO guidelines.