Quality Assurance Sample Management

Location: Indianapolis, Indiana

Payrate: $23.00 an hour

The Quality Assurance – Sample Management & Labels role provides quality oversight for the management, labeling, and

lifecycle activities of clinical trial materials.

This position ensures compliance with applicable Good Manufacturing Practices (GMPs), Good Distribution Practices (GDPs), internal standards, and procedures related to sample management and labeling processes.

The role supports both documentation review and hands-on warehouse operations, ensuring accuracy, traceability, and regulatory compliance throughout all activities.

Key Responsibilities:

• Perform Quality Assurance verification of documentation related to the receipt, inspection, storage, retention, and

disposition of clinical trial samples, including retention, reference, and RIB samples.

• Coordinate sample receipt and inspection activities with cross-functional teams, including API, Drug Product (DP), and

vTeams.

• Verify sample-related data accuracy and ensure proper documentation and traceability within SAP and other quality

systems.

• Support annual RIB sample inspections and ensure findings are documented and addressed appropriately.

• Manage and oversee the processing of samples for destruction in accordance with approved procedures and regulatory

requirements.

• Review and approve clinical trial labels to ensure compliance with regulatory, protocol, and internal quality standards.

• Review procedures, tools, and workflows; provide feedback and recommendations for continuous process improvement.

• Initiate, complete, and provide Quality Assurance oversight for Incident/Issue Investigations (ICI), change controls, and

deviations.

• Support audits, inspections, and internal assessments as needed.

• Perform other duties as assigned to support Quality Assurance and business objectives.

Requirements:
Education: Bachelor’s Degree or Associate Degree in addition to relevant prior work experience.

Experience & Skills:

• Basic computer proficiency, including Microsoft Office and experience with quality and enterprise systems such as

TrackWise, QDocs, SAP, and web-based applications.

• Previous experience working in a warehouse or controlled storage environment.

• Willingness and ability to work in a chilled environment (approximately 5°C).

• Physical ability to perform job requirements, including standing, bending, and lifting up to 50 lbs.

• Availability to work off-hours and weekends as business needs dictate.

• Strong attention to detail and documentation accuracy.

• Knowledge of GMP/GDP principles and quality systems.

• Effective communication and coordination across cross-functional teams.

• Ability to balance administrative responsibilities with hands-on operational tasks.

• Proactive mindset with a focus on continuous improvement and compliance.

Benefits:
Keywords provides all its contingent workforce with:

Medical, dental and vision benefits

Paid time off (including sick and select holidays)

401(k) enrollment with 3% employer matching

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law

Role Information: EN

Studio: Keywords Studios

Location: Indianapolis, IN

Area of Work: Quality Assurance Sample Management

Service: Embedded Technologies Team

Employment Type: Contractor

Working Pattern: Full Time

This Organization Participates in E-Verify

Keywords Studios is committed to fair and ethical hiring practices. We expect candidates to conduct themselves with honesty and to participate in all applications and interviews independently, presenting their own knowledge and experience. Candidates should refrain from using AI assistance or third-party tools or services that could influence, capture, or otherwise interfere with the authenticity of the assessment process