Quality Assurance (CAPA) Specialist

Quality Assurance (CAPA) Specialist

Location: Corona, CA (Onsite)

Schedule: Monday – Friday, 8:00 AM – 5:00 PM (40 hours/week, 1st Shift)

Pay Rate: $35.00 – $60.00 per hour (Dependent on Experience / BOE)

Position Type: Contract-to-Hire

Industry: Pharmaceutical/Medical Device

Position Overview

Currently seeking Quality Assurance (CAPA) Specialist for a contract-to-hire opportunity with a cutting-edge client in Corona, CA.

Reporting to the Quality Assurance (QA) Manager, this role is critical in ensuring that facility quality system requirements are met and maintained. You will provide management with key data analyses, drive continuous improvement, and assume advanced responsibilities—including leading investigations, risk assessments, and representing the client during customer audits . Responsible for addressing a backlog of CAPA and non-conformance documentation.

Key Responsibilities

• CAPA & Investigations: Perform comprehensive investigations, root cause analyses, and risk assessments for deficiencies. Lead monthly CAPA meetings and assist with corrective action, preventive action, and effectiveness verification action plans (must have direct experience opening, writing, and closing CAPAs) .

• Data Analysis & Reporting: Provide data analysis reflecting the status of the plant quality system, compile inputs for the Total Quality Management Report, and support Management Review metrics.

• Quality Operations & Compliance: Issue releases for processed products, manage product Hold/Release statuses, and assist with document change requests in electronic quality management systems (e.g., MERLIN).

• Systems Administration: Serve as an Administrator for the electronic training management system (LMS) and oversee instrument calibration/verification reviews in the electronic asset management system (EAM).

• Audits & Regulatory Support: Actively assist in all activities for FDA, customer, and regulatory audits, serving as a designated representative in customer audits as assigned.

• Technology & Validation Support: Perform data gathering/analysis for new customer products, assist with tote loading diagrams/PQ documentation, and support the QA Manager with dose measurement system calibrations.

• Leadership Support: Serve as Deputy to the facility QA Manager as needed and perform standard QA technician duties to ensure seamless daily operations.

Qualifications & Requirements

• Experience & Education: Bachelor’s Degree OR a minimum of 5 years of professional experience working in a quality role at a ISO 13485 medical device company or similar, sterilization, or pharmaceutical environment.

• Core Requirement: Demonstrated, hands-on experience owning CAPA Investigations (end-to-end: opening, writing, and closing).

• Communication: Ability to read, write, and speak fluent English.

• Technical Skills: Highly proficient using computers, databases, and spreadsheets to analyze quality data. Proficiency with MasterControl software.

What Happens Next

Once you apply, you'll proceed to next steps if your skills and experience look like a good fit. But don't worry—even if this position doesn't work out, you're still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

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 Affirmative 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.