Specialist Quality Control - Micro

Kelly Science, Engineering, Technology & Telecom; Juncos (PR); On-site; USD 43,000 - 62,000; Full time

Benefits offered by this job

Bi-Weekly pay (W-2)

Paid vacations

Paid holidays

Job summary

Kelly Science seeks a Specialist Quality Control to support QC microbiology operations in Juncos, PR. This on-site role emphasizes Bioburden, Endotoxin, Sterility, and Mycoplasma testing with validation activities.

You will drive method validation, document control, and audit readiness while ensuring GMP/GLP compliance and high-quality reporting in a fast-paced pharmaceutical setting.

Qualifications

• Master’s or Bachelor’s in a scientific field with related pharma experience.
• Experience in GMP/GLP environments and quality systems.
• Strong technical writing and validation documentation skills.

Responsibilities

• Support QC microbiology lab operations incl. Bioburden, Endotoxin, Sterility, Mycoplasma testing and validation.
• Lead method validation activities and troubleshoot complex assay issues.
• Ensure GMP/GLP compliance and internal quality standards.
• Evaluate events, conduct root cause analysis, and implement CAPA.
• Author, review, and approve technical documents and reports.

Skills

Technical writing

Bioburden testing

Endotoxin testing

Sterility testing

Mycoplasma testing

Method validation

CAPA

Analytical testing

Analytical reporting

Education

Master's Degree in a scientific discipline

Bachelor's Degree in a scientific discipline

Tools

HPLC

Analytical laboratory methods

Job description

At Kelly® Science, we're passionate about helping you find a job that works for you. How about this one?

We're seeking Specialist Quality Control to work for one of our top Biotechnology Industry client at Juncos, PR.

Why you should apply

Salary: $38.00 hr - W2

Shift: 8hrs shift | Administrative - Monday through Friday, 8:00 AM - 5:00 PM with work schedule flexibility as required to support 24/7 operations

Job Type: On Site position at Juncos Puerto Rico, US

Industry Leader: Work at a premier pharmaceutical manufacturing organization

Project Leadership: Lead impactful packaging engineering projects

Innovative Environment: Gain experience with advanced packaging technologies and compliance standards

Collaborative Culture: Join cross-functional teams focused on improvement

Benefits: Bi-Weekly pay by W-2, Vacations, Sick & Holidays paid*, Christmas bonus* (*Must comply with minimum established requirements to qualify)

Requirements & Qualifications

• Education: Master's Degree in a scientific discipline with 2+ years directly related experience OR Bachelor's Degree in a scientific discipline with 4+ years directly related experience. Background in Microbiology, Biological Sciences, Biotechnology, or related field
• Industry Experience: Experience in a regulated pharmaceutical, biotechnology, medical device, or laboratory environment
• Technical Skills: Strong technical writing skills; experience preparing scientific reports, protocols, and validation documentation. Microbiology laboratory experience: Bioburden, Endotoxin, Sterility, Mycoplasma Testing, Microbial Method Validation. Analytical testing and method validation proficiency
• Regulatory Knowledge: Understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and quality system requirements
• Problem-Solving: Experience in deviation investigations, root cause analysis, and CAPA implementation
• Core Competencies: Analytical, problem-solving, organizational, and communication skills. Ability to work independently and manage multiple priorities in a fast-paced environment
• Preferred Qualifications: Experience supporting new product introductions and method transfer activities Hands-on experience with HPLC and analytical laboratory methods. Prior role as a technical SME during inspections or audits

Key Responsibilities

• Microbiology Expertise: Support QC laboratory operations, including Bioburden, Endotoxin, Sterility, Mycoplasma Testing, and Microbial Method Validation.
• Method Validation & Analytical Testing: Lead and approve method validation activities and troubleshoot complex assay issues.
• Regulatory Compliance: Ensure adherence to GMP, GLP, and internal quality standards.
• Deviation Management & CAPA: Evaluate events, conduct root cause analysis, and recommend corrective actions.
• Technical Leadership: Author, review, and approve technical documents, laboratory reports, and provide guidance to laboratory staff.
• Audit Readiness: Lead and participate in audits, supporting cross-site quality initiatives.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.