Product Surveillance Quality Associate II (TTH)

By | June 12, 2026

Product Surveillance Quality Associate II (TTH)

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Job ID: 10265949

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Bloomington, IN, US

Scientific

Bachelors Degree

Full Time, Temp to Hire

$45/hr-$46/hr

Experienced (Non-Manager)

On-site

Biotechnology/Pharmaceuticals

First Shift (Day)

Bloomington, IN, US

$45/hr-$46/hr

Experienced (Non-Manager)

Full Time, Temp to Hire

Biotechnology/Pharmaceuticals

On-site

Scientific

Bachelors Degree

First Shift (Day)

Apply Now Applied

Job details

Kelly Science & Clinical

Product 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

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