Specialist Quality Control- 35982

CIS International LLC; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

CIS International LLC in Juncos, Puerto Rico, seeks a senior molecular biology and microbiology specialist to lead testing and development efforts on-site.

You will drive GMP/GLP compliant workflows, analyze complex data, prepare technical reports, and coordinate cross-functional teams across multiple sites and external resources. A doctorate or masters with relevant experience is preferred, with a strong microbiology background.

Qualifications

• PhD or MS with 2+ years related experience in microbiology or molecular biology.
• Bachelor's with 4+ years related experience considered equivalent for certain roles.
• Background in microbiology preferred.

Responsibilities

• Provide technical guidance and reports; ensure communication between groups.
• Resolve technical issues and troubleshoot assays as needed.
• Ensure GMP/GLP compliance and safety practices.
• Develop, revise and audit controlled documents impacting multiple sites.
• Lead lab investigations and audit teams; supervise staff as needed.
• Interact with regulatory agencies in writing and meetings.

Skills

GMP compliance

GLP

Data analysis

Technical writing

Communication

Project management

Independent work

Education

Doctorate or Masters + 2 years related experience

Bachelors + 4 years related experience

Microbiology background

Job description

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
• Preferred: Background Microbiology

PREFERRED QUALIFICATIONS

• echnical Writing for Microbiology Method Validations reports for new product introductions.
• 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 causes.

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: 2months for the first contract, with a high possibility of extension based on performance and budget.
• Administrative Shift(weekends and overtime may also be required).
• Expected hiring date: December 2026