Specialist Quality Control

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 general direction, functions as the technical specialist for testing & development in areas of molecular biology and microbiology. 
• 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. 

Qualifications:

• Bachelor Degree
• Five (5) years of directly related experience
• Experience in LIMS, LMES, Empower, GMP documentation or analytical testing execution.
• Knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution.
• Extensive knowledge and application of GMPs/CFRs
• Extensive knowledge of all testing of pharmaceutical/biological products
• Advanced scientific data analysis and interpretation skills