Specialist Quality Control 35983

Inteldot; Juncos (PR); Presencial; USD 85.000 - 120.000; Jornada completa

Descripción de la vacante

Inteldot, a long-time life sciences partner, seeks a technical specialist in Puerto Rico to lead testing and development in molecular biology and microbiology. You will tackle complex issues across multi-site teams and external resources.

You will ensure GMP/GLP compliance, develop and audit controlled documents, and mentor staff. Strong English and Spanish communication and project management skills are essential.

Formación

• Experience in microbiology, HPLC, and analytical methods.
• Experience in Method Validation, Method Transfer, Method Qualification.
• Experience in project management.
• Scientific Data Analysis.
• Strong knowledge in Microsoft Excel as a Tool for Data Analysis.
• Sample Management.
• Basic Knowledge on equipment preventive maintenance and troubleshooting.
• Agile on prioritization of critical tasks.
• Ability to develop inspection or qualification protocols in a short timeframe period.
• Strong negotiation skills.
• Good communication skills.
• Able to work with multi-functional Teams.
• Able to communicate effectively in both English and Spanish.

Responsabilidades

• Provide technical guidance, reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues.
• Resolve technical issues and troubleshoot for assays as necessary
• Ensure lab compliance including 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.

Conocimientos

Molecular biology

Microbiology

HPLC

Analytical methods

Method validation

Method transfer

Method qualification

Project management

Data analysis

Excel

Sample management

Equipment maintenance

Troubleshooting

Agile prioritization

Protocols development

Negotiation

Communication

Bilingual English/Spanish

Team collaboration

Educación

Doctorate or Masters + related experience

Descripción del empleo

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.

Administrative shift 8:00am – 5:00pm

Requirements

• Experience in Microbiology, HPLC, and analytical methods.
• Experienced in Method Validation, Method Transfer, Method Qualification.
• Experience in project management.
• Scientific Data Analysis.
• Strong knowledge in Microsoft Excel as a Tool for Data Analysis.
• Sample Management.
• Basic Knowledge on equipment preventive maintenance and troubleshooting.
• Agile on prioritization of critical tasks.
• Ability to develop inspection or qualification protocols in a short timeframe period.
• Strong negotiation skills.
• Good communication skills.
• Able to work with multi-functional Teams.
• Able to communicate effectively in both English and Spanish.

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.