Specialist Quality Control- 35983

CIS International LLC; Juncos (PR); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

CIS International LLC is seeking a technical specialist in molecular biology and microbiology for an on-site, full-time role in Juncos, Puerto Rico. The project focuses on complex testing issues across multiple sites and may involve external resources.

The candidate will guide technical teams, develop programs, and ensure GMP/GLP compliance. Requirements include advanced degrees with related experience and strong knowledge of GMP, QC practices, HPLC, and analytical methods.

Formación

• Advanced degree or equivalent with substantial related experience.
• Experience with GMP/GLP and quality systems.

Responsabilidades

• Provide technical guidance, reports and data analysis across groups.
• Troubleshoot assays and ensure compliance with GMP/GLP.
• Develop, audit and revise controlled documents affecting multiple sites.
• Lead cross-functional teams and interact with regulatory bodies.

Conocimientos

Molecular biology

GMP compliance

Data analysis

Technical writing

Project management

Educación

Doctorate or Masters + 2 years related experience

Bachelor's + 4 years related experience

Associates + 8 years related experience

High school/GED + 10 years related experience

Preferred Microbiology background

Herramientas

HPLC

LIMS

Descripción del empleo

SUMMARY

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.

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.
• Performs special projects as requested by supervisor, May supervise employees as necessary to meet technical requirements.

EDUCATION

• Doctorate orMasters + 2 years of directly related experience.
• Bachelors + 4 years of directly related experience.
• Associates + 8 years of directly related experience.
• High school/GED + 10 years of directly related experience.
• Preferred Background: Microbiology

PREFERRED QUALIFICATIONS

• The candidate will be working with deviation within the Quality Control Area. Experience in Microbiology, HPLC, and analytical methods is preferred.

SKILLS

• Understand, support and demonstrate the AMGEN values.
• Excellent communication skills, facilitation and presentation skills.
• Excellent technical writing skills.
• Strong computer operation skills including work processing, presentation, database and spreadsheet application skills.
• Excellent project management and organizational skills including the ability to independently understand, follow, implement complex instructions and follow assignments through to completion.
• Advanced skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities.
• Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution.
• Extensive knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility.
• Knowledge of pharmaceutical processes.
• Strong knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products.
• Knowledge of basic international regulations and practices pertaining to the testing of pharmaceutical/biological products.
• Extensive knowledge and application of GMPs/CFRs.
• Ability to evaluate compliance issues.
• Skill in evaluating and documenting according to Company and various guidelines.
• Proficient at maintenance, troubleshooting and operation of equipment in area of expertise.
• Advanced scientific data analysis and interpretation skills.
• Advanced skills in solving complex problems.
• Advanced data trending and evaluation.
• Strong skill in working independently and to effectively interact with various levels.
• Ability to interact with regulatory agencies both orally and in writing.
• Initiate, coordinate and lead cross functional teams.
• Excellent skill in leading, motivating, influencing, and negotiating.

WORK METHODOLOGY

• Full on site job in Juncos, PR
• Full time job
• Expected project duration: 5months for the first contractwith a high possibility of extension based on performance and budget.
• Administrative Shift(weekends and overtime may also be required).
• Open Positions: 1
• Expected hiring date: December 2026