Specialist Quality Control 35175

Inteldot has over 15 years of experience in the life sciences industry, with allocations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Job Description

Under general direction, functions as the technical specialist for testing and development in areas of molecular biology and microbiology. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources.

Requires availability for 1st or 2nd shift. 1st shift with requirements to support other shift based on available windows for execution

Requirements

• Laboratory Equipment Validation
• Periodic Monitoring
• Periodic Review
• Equipment Data Integrity, Procurement
• Decommissioning process
• New equipment Introduction and Maintenance
• Others: Biochemistry (eg. Compendial testing, physical methods), High-Performance Liquid Chromatography (HPLC), Microbiology (eg. Sterility, Endotoxin, Bioburden)

Functions:

• Responsible for providing technical guidance, provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise.
• Resolve technical issues and troubleshoot for assays as necessary
• Ensure lab compliance which includes Implementing procedures that enhance GMP, GLP and safety.
• Manage existing and/or develop and implement new programs, processes and methodologies.
• Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.
• Approve lab investigations, Lead audit teams
• May serve as subject matter expert to develop technical training.
• May perform routine work in a specific area of responsibility as necessary.
• Represents the department/organization on various teams, independently responsible for following through on multi-site action items.
• May interact with regulatory agencies regarding area(s) of responsibility including written responses.
• May resolve issues with outside resources.

Education:

• Doctorate or Masters + 2 years of directly related experience or Bachelors + 4 years of directly related experience or Associates + 8 years of directly related experience or High school/GED + 10 years of directly related experience.
• Engineering (Chemical, Environmental, Mechanical, Electrical), or Chemist/Biology (with experience in Equipment Validation)