JT983 - SPECIALIST QUALITY CONTROL

Quality Consulting Group, LLC; Juncos (PR); Presencial; USD 70.000 - 100.000; Jornada completa

Descripción de la vacante

Quality Consulting Group, LLC in Puerto Rico and the USA is seeking a Technical Specialist for testing and development in molecular biology and microbiology. You will work with a dynamic team in a world-class manufacturing environment.

The role emphasizes solving complex technical issues across sites, providing guidance, data analysis, and ensuring GMP/GLP and safety compliance. You will lead audits, develop programs, and train staff as needed.

Formación

• Bachelor’s degree in Microbiology.
• Experience with Method Validation, Method Transfer and Quality processes.
• Experience with deviation in Quality Control.
• Experience in Microbiology, HPLC, and analytical methods preferred.
• Administrative duties are part of the role.

Responsabilidades

• Technical specialist for testing and development in molecular biology and microbiology.
• Complex technical issues across multiple sites or with outside resources.
• Provide technical guidance, reports, data analysis and ensure communication between groups.
• Resolve technical issues and troubleshoot assays as necessary.
• Ensure GMP, GLP and safety compliance in the lab.
• Manage and develop new programs, processes and methodologies.
• Develop, revise and audit complex controlled documents with multi-site impact.
• Approve lab investigations and lead audit teams.
• May serve as SME to develop technical training.
• Represent the department on teams and follow through on multi-site action items.
• Interact with regulatory agencies regarding responsibilities and written responses.

Conocimientos

Microbiology

HPLC

Analytical methods

Quality processes

Educación

Bachelor’s degree in Microbiology

Herramientas

Quality control systems

Descripción del empleo

QUALITY CONSULTING GROUP, a leader inthe 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:

• 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.
• 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.
• 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.

Qualifications:

• Bachelor’s degree in preferable Microbiology
• Management Method Validation, Method Transfer and Quality processes.
• Experience working with deviation within the Quality Control Area.
• Experience in Microbiology, HPLC, and analytical methods is preferred.
• Administrative Shit

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.