Sr Quality Assurance Technician

Kelly Services; Corona (CA); On-site; USD 41,000 - 55,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Telemedicine

Life insurance - term

Life insurance - whole

Accident insurance

Critical illness coverage

Legal plan

Short-term disability

Retirement savings plan

Service bonus

Holiday pay plans

Transit spending account

Paid sick leave

Job summary

Kelly Science & Clinical is seeking a Sr. Quality Assurance Technician for a contract-to-hire role in Corona, CA. The position supports QA Manager and includes data analysis, CAPA investigations, and audits, with on-site work on a first shift.

You will interact with facility, corporate staff, and customers, manage calibration and data analysis, and assist with regulatory audits while advancing quality initiatives.

Qualifications

• Bachelor's degree in a relevant field or 5+ years QA/medical device experience.
• Fluent reading, writing and speaking English.
• Experience owning CAPA investigations.
• Proficient with computers and data analysis in spreadsheets/databases.

Responsibilities

• Provide information and data analysis on the plant quality system.
• Input and trend monthly Quality Management data for review.
• Perform quality data analysis for Management Review.
• Investigate deficiencies, perform root cause and risk assessments.
• Assist with corrective/preventive actions and verification plans.
• Lead monthly CAPA meetings and coordinate audits.
• Release processed products after review for defects.
• Administer electronic training management systems (LMS).
• Manage calibration/verification of instruments and calibration reviews in EAM.
• Coordinate facility document changes in MERLIN and translations if needed.
• Support FDA, customer, and regulatory audits.

Skills

CAPA investigations

Data analysis

English proficiency

Quality systems

Education

Bachelor's degree

Job description

Sr. Quality Assurance Technician

Kelly® Science & Clinical is seeking a Sr. Quality Assurance Technician for a contract-to-hire position at a cutting-edge client in Corona, CA. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Pay: $35/hour

Schedule: Monday-Friday, 8:00 AM-5:00 PM (1st shift) Onsite

Overview

Reporting to the Quality Assurance (QA) Manager, the Senior Quality Assurance (QA) Technician is responsible for assisting the facility QA Manager in ensuring the quality system requirements are met and maintained. This role assists in providing management with information and data analysis on all key aspects of daily quality related metrics to the operation, which is used by both facility and corporate management to determine if the quality system is adequate and operating as designed. This information and data is also used to provide guidance for corrective actions and continuous improvement.

The Senior QA Technician will assume additional responsibilities over those assigned to the QA Technician, including representing our Client in customer audits (as assigned), completing investigations, risk assessments, and other quality system related activities as identified and assigned by the facility QA Manager. The Senior QA Technician must effectively interface with facility personnel, corporate staff, and customers.

Responsibilities

• Provides information and data analysis reflecting the status of the plant quality system
• Completes inputs and trend analysis for monthly review of the Total Quality Management Report
• Performs quality data analysis for Management Review
• Performs investigations, root cause, and risk assessment for deficiencies; documents findings in the electronic quality control management system (MERLIN)
• Assists with corrective action, preventive action, and effectiveness verification action plans
• Conducts monthly CAPA meetings
• Issues release of processed products, including processing runs that require review for possible deficiencies
• Authorized to remove product from Hold status
• Serves as an Administrator for the electronic training management system (LMS)
• Manages the calibration/verification of instruments and calibration reviews/approvals in the electronic asset management system (EAM) for maintenance and calibrations
• Completes facility document change requests in the electronic quality control management system (MERLIN) and procedure translations, if applicable
• Assists in all activities relevant for FDA, customer, and regulatory audits
• Representative in customer audits, as assigned by the QA Manager
• Completes expert user training in one electronic management system in use at the facility (e.g., E1, SADA KonnTRACK, LMS Administrator, VeriCycle)
• Performs the responsibilities and duties of the Quality Assurance Technician (if the position does not exist at the facility)
• Serves as Deputy to the facility QA Manager, as needed
• Other Quality Assurance / Validation (if applicable) duties as assigned

Gamma & E-Beam Technology

• Performs data gathering and analysis for new customer products
• Assists with / completes applicable tote loading diagrams and PQ documentation
• Assists the QA Manager in calibration of dose measurement systems

Qualifications

• Bachelor's Degree or a minimum of 5 years of experience working in a quality / medical device / sterilization / pharmaceutical environment preferred
• Ability to read, write, and speak fluent English
• Experience owning CAPA investigations
• Proficient using a computer and able to analyze data in a database/spreadsheet

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.

• medical
• dental
• vision
• telemedicine
• term life
• whole life
• accident insurance
• critical illness
• a legal plan
• short-term disability
• retirement savings plan
• service bonus
• holiday pay plans (earn up to eight paid holidays per benefit year)
• transit spending account
• 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 Aff…?