Senior Specialist QA

Kelly Services; Juncos (PR); On-site; USD 86,000 - 105,000; Full time

Benefits offered by this job

Bi-Weekly pay by W-2

Vacations, Sick & Holidays paid

Christmas bonus

Job summary

Kelly Science is seeking a Senior Specialist QA to lead QA activities for a biotechnology client in Juncos, PR. The role focuses on oversight of manufacturing processes, validation, investigations, and quality systems to ensure GMP compliance and continuous improvement.

You will collaborate with cross-functional teams, manage risk, review protocols and reports, and support new product introductions in a 24/7 operation environment. Bilingual communication is valued.

Qualifications

• Doctorate with 2+ years, Master’s with 4+ years, or Bachelor’s with 6+ years of directly related QA/Validation/Manufacturing experience.
• Strong knowledge of GMP, Data Integrity, Quality Systems, Change Control, Risk Management, and validation lifecycle activities.
• Experience supporting manufacturing processes, process validation, equipment qualification, facilities commissioning and qualification, and CSV.
• Proven ability to lead investigations, assess compliance issues, perform risk assessments, and drive CAPAs.
• Experience with quality and manufacturing systems including KNEAT, CDOCS, SCADA, TrackWise, Maximo, or similar platforms.
• Strong leadership, project management, communication, and cross-functional collaboration; ability to influence stakeholders and regulators.
• Strong technical documentation, written and verbal communication in English and Spanish.

Responsibilities

• Lead QA oversight of manufacturing processes, validation activities, investigations, and quality systems.
• Review and approve protocols, reports, and quality documents; ensure GMP compliance.
• Partner with cross-functional teams to support new product introductions and risk management.

Skills

QA leadership

GMP compliance

Validation

Manufacturing experience

CAPA leadership

Cross-functional collaboration

Documentation

English & Spanish

Education

Doctorate (PhD) in related field

Master’s in related field

Bachelor’s in related field

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 Specialist QA 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 Specialist QA:

• 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.

• Strong knowledge of GMP regulations, Good Documentation Practices, Data Integrity, Quality Systems, Change Control, Risk Management, and validation lifecycle activities.

• Experience supporting manufacturing processes, process validation, equipment qualification, facilities/utilities commissioning and qualification, and Computer System Validation (CSV).

• Demonstrated ability to lead 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 leadership, project management, communication, and cross-functional collaboration skills, with the ability to influence stakeholders and interact with regulatory agencies.

• Strong technical documentation, written and verbal communication skills (English & Spanish)

The Senior Specialist QA 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 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. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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 Affinitive 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.