Senior Quality Control Specialist: GMP/GLP Microbiology & Audits

Quality Consulting Group, LLC; Juncos (PR); Presencial; USD 70.000 - 100.000; Tempo integral

Resumo da vaga

QUALITY CONSULTING GROUP, LLC is seeking a technical specialist for testing and development in molecular biology and microbiology in Puerto Rico and the USA. You will work with a highly enthusiastic team in a world-class manufacturing environment.

Responsibilities include providing reports, data analysis, ensuring cross-functional communication, and maintaining GMP/GLP and safety compliance. The role may involve audits, document control, and regulatory interactions.

Qualificações

• Bachelor's Degree in Science (Preferred: Background Microbiology)
• Technical writing for microbiology method validation reports
• Knowledge in bioburden, endotoxin, low endotoxin recoveries, sterility testing, MMV and mycoplasma testing
• Provide technical support to the microbiology lab
• Design special studies
• Support deviation records owners as evaluating events and root cause
• Administrative shift

Responsabilidades

• 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.
• 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.
• 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.

Conhecimentos

Technical writing

Bioburden testing

Endotoxin testing

Sterility testing

Mycoplasma testing

Root cause analysis

GMP/GLP compliance

Audit support

Formação

Bachelor's Degree in Science (preferred microbiology)

Descrição da vaga

QUALITY CONSULTING GROUP, LLC is seeking a technical specialist for testing and development in molecular biology and microbiology in Puerto Rico and the USA. You will work with a highly enthusiastic team in a world-class manufacturing environment.

Responsibilities include providing reports, data analysis, ensuring cross-functional communication, and maintaining GMP/GLP and safety compliance. The role may involve audits, document control, and regulatory interactions.