Product Surveillance Quality Associate II (TTH)

Job Description

Job Description

Kelly Science & ClinicalProduct Surveillance Quality Associate II (Contract-to-Hire)

Location: Bloomington, IN (Hybrid – approximately 1 day onsite per week after training)
Schedule: Full-Time, Monday–Friday
Shift: Flexible start times (typically 7:00 AM–4:00 PM or 8:00 AM–5:00 PM)
Pay Rate: $44.00–$45.70/hour
Contract Type: Contract-to-Hire (Contract through December 2026 with conversion potential)

Position Overview

Kelly Science & Clinical is seeking a Product Surveillance Quality Associate II to support complaint investigations and quality surveillance activities within a regulated pharmaceutical manufacturing environment. This role offers the opportunity to transition into a permanent position following the initial contract period.

The successful candidate will investigate customer-reported product complaints, perform root cause analysis, author technical reports, and collaborate with quality, manufacturing, and technical teams to ensure timely and compliant complaint resolution.

Responsibilities

• Investigate and manage customer product complaints from initiation through closure
• Communicate with customers to obtain information and provide updates
• Review batch records, SOPs, and manufacturing documentation
• Perform root cause analysis and support CAPA activities
• Evaluate complaint samples and investigation data
• Collaborate with SMEs and manufacturing personnel to determine corrective actions
• Author technical investigation reports and complaint closures
• Maintain documentation within electronic quality systems

Qualifications

Required:

• Bachelor's degree in Chemistry, Biology, Engineering, or related scientific discipline
• Minimum 2 years of experience in pharmaceutical, biotech, medical device, or regulated manufacturing environments
• Experience with complaint investigations, deviations, CAPAs, or quality systems
• Strong technical writing and documentation skills
• Excellent communication and problem-solving abilities

Preferred:

• FDA-regulated industry experience
• Root cause analysis experience
• Experience with Veeva, TrackWise, or similar quality systems

Technical Skills

• Complaint Investigations
• Root Cause Analysis (RCA)
• CAPA Management
• Technical Writing
• Batch Record Review
• GMP/cGMP Compliance
• Quality Systems (Veeva preferred)
• Microsoft Office Suite

Work Environment

• Hybrid schedule following training
• Increased onsite presence during onboarding

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. 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 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.