Senior QA Auditor

Kelly Services; Juncos (PR); On-site; USD 56,000 - 76,000; Full time

Benefits offered by this job

Bi-Weekly pay

Paid time off

Christmas bonus

Job summary

Kelly Services is seeking a Senior QA Auditor for a biotechnology client in Juncos, PR. The role focuses on leading QA activities, ensuring GMP compliance, and supporting 24/7 manufacturing operations while coordinating with cross-functional teams.

The position requires strong knowledge of validation, data integrity, and quality systems, with experience in audits and CAPA. Fluency in English and Spanish is preferred for effective collaboration.

Qualifications

• Experience in QA, validation or manufacturing within biotech or pharma.
• Knowledge of GMP, data integrity, change control and risk management.
• Experience auditing manufacturing processes and CSV would be advantageous.
• Strong documentation and bilingual communication abilities (English/Spanish).
• Leadership in audit investigations and CAPA implementation.

Responsibilities

• Serve as QA technical lead for manufacturing processes and validation.
• Oversee investigations, audits, and quality system compliance.
• Review protocols, reports, and environmental characterization data.
• Collaborate with cross-functional teams to drive CAPA and continuous improvement.

Skills

GMP regulations

Data Integrity

Quality Systems

Audit investigations

CAPA

Risk assessment

Process validation

English

Spanish

Education

Bachelor’s degree in Life Science or Engineering

Master’s degree preferred

Doctorate with 2+ years experience

Tools

KNEAT

CDOCS

SCADA

TrackWise

Maximo

Job description

At Kelly ® Science, we’re passionate about helping you find a job that works for you.

We’re seeking Senior QA Auditor to work for one of our top biotechnology industry clients at Juncos, PR .

Salary: $48.00 hr

Shift: 8hrs shift | Administrative - with work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.

Why you should apply to be Senior QA Auditor:

• Competitive pay rate and opportunity for professional growth
• Work with a leading organization in the manufacturing sector
• Engage in diverse, impactful engineering projects
• Contribute to a culture of safety, innovation, and operational excellence
• Bi-Weekly pay by W-2
• Vacations, Sick & Holidays paid*
• Christmas bonus *

*Must comply with minimum established requirements to qualify.

This job might be an outstanding fit if you have the following qualifications:

• Doctorate with 2+ years, Master’s with 4+ years, or Bachelor’s with 6+ years of directly related Quality Assurance, Validation, or Manufacturing experience. ( Degrees in Life Science or Engineering)
• Strong knowledge of GMP regulations, Good Documentation Practices, Data Integrity, Quality Systems, Change Control, Risk Management, and validation lifecycle activities.
• Experience auditing and supporting manufacturing processes, process validation, equipment qualification, facilities/utilities commissioning and qualification, and Computer System Validation (CSV).
• Demonstrated ability to lead audit investigations , assess compliance issues, perform risk assessments, and drive effective corrective and preventive actions (CAPAs).
• Experience working with quality and manufacturing systems including KNEAT, CDOCS, SCADA, TrackWise, Maximo, or similar platforms.
• Strong technical documentation, written and verbal communication skills (English & Spanish)

The Senior QA Auditor serves as the Quality Assurance technical lead, providing oversight and approval of manufacturing processes, validation activities, investigations, and quality systems. Partner with cross-functional teams to ensure GMP compliance, support new product introductions, manage quality risks, and drive continuous improvement across manufacturing operations. Designs, monitors or conduct experimental strategies. Provides data analysis and interpretation and assesses impact of the data on the project. Review and approve manufacturing processes, validation protocols and reports, environmental characterization reports, planned incidents, and sanitary utility system releases while ensuring compliance with GMP requirements. Lead quality audit investigations, represent QA on cross-functional teams and governance boards, support new product introductions, and maintain site quality programs and procedures.

Helping you discover what’s next in your career is what we’re all about, so let’s get to work.

#Kelly80 #SETTPuertoRico #QA #biotechnology

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 (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .

Kelly Services is proud to be an Equal Employment Opportunity and Affirmitive Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s 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.