Quality Systems Specialist

Quality Systems Specialist (Hybrid)

Location: Waltham, MA

Pay Rate: $40-$50/hour

Schedule: Hybrid - Onsite Tuesday, Wednesday, and Thursday

Job Overview

We are seeking an experienced Quality Systems Specialist to support global Quality Systems operations within a regulated pharmaceutical, clinical, or healthcare environment. This hybrid role plays a critical part in ensuring Quality Systems are compliant, validated, and fit for intended use in accordance with FDA, EU, and ICH regulatory requirements.

The ideal candidate brings strong technical expertise, quality systems knowledge, and experience working with electronic Quality Management Systems (eQMS).

Key Responsibilities

• Support global Quality Systems (QS) operations in compliance with applicable SOPs and regulatory standards.
• Assist in governance and administration of Quality System applications, including process harmonization across multiple sites.
• Gather system enhancement and maintenance requirements by collaborating with Site Process Owners, business SMEs, and cross-functional teams.
• Participate in user forums to collect ongoing requirements, prioritize enhancements, and triage system issues.
• Track and follow up on system requests, issues, and projects; communicate status updates to management and stakeholders.
• Initiate, manage, and close change controls, ensuring all required documentation is completed accurately and on time.
• Maintain systems in a validated state, including periodic user access reviews, deviation management, and CAPA support.
• Support investigation, escalation, and resolution of Quality System issues.
• Participate in validation activities, including requirements gathering, validation planning, IQ/OQ documentation, test plan and script authoring, execution, discrepancy management, and validation summary reports.
• Serve as a liaison with IT and system vendors, supporting ongoing communication and issue resolution.
• Provide system support, training, and onboarding for new users.
• Generate and analyze quality metrics to support system performance and compliance.
• Support system upgrades and releases by assessing new features and providing recommendations.
• Maintain and update user documentation as system functionality evolves.

Required Qualifications

• Bachelor's degree or higher in a technical, scientific, quality, or computer-related discipline.
• 3-6 years of experience in a regulated environment such as pharmaceutical, biotech, clinical research, or healthcare manufacturing.
• Strong knowledge of Quality Management Systems (QMS) and quality system processes.
• Proficiency with Microsoft Word and Excel.
• Working knowledge of US FDA and European regulatory requirements, GAMP, and phase-appropriate validation requirements.
• Familiarity with ICH guidelines and regulatory compliance standards.

Preferred Skills & Experience

• Hands-on experience with Veeva Vault QualityDocs, TrackWise, and/or ComplianceWire.
• Experience supporting validated systems in a global or multi-site environment.
• Strong documentation, communication, and stakeholder collaboration skills.

Employee Benefits

• Medical, dental, vision, and pet insurance
• 401(k) Retirement Savings Plans
• Employee Assistance Program (EAP)
• Commuter/Parking Accounts
• People Perks
• Health Savings Account (HSA)
• AD & D Insurance

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Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.