Product Surveillance Quality Associate II; temp

Kelly Science & Clinical Product Surveillance Quality Associate II (Contract)

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 through December 2026

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 position is a temporary assignment through December 2026 covering a team member’s leave of absence. 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.

• 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

• 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

• FDA‑regulated industry experience
• Root cause analysis experience
• Experience with Veeva, Track Wise, or similar quality systems

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

• Hybrid schedule following training
• Increased onsite presence during onboarding

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.