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Peak Performers · 13 hours ago

Quality System Specialist

Waltham, MA

Contract

Hybrid

Mid, Senior Level

$50/hr - $50/hr

3+ years exp

Peak Performers has partnered with a global pharmaceutical company to assist in their search for a hybrid Quality System Specialist. In this contract position, you will be responsible for supporting the global Quality Systems and their operations in ensuring compliance and fit for intended use in accordance with applicable global SOPs.

Employment

Growth Opportunities

No H1B

Responsibilities

Assist in governance of Quality System applications, including harmonization of processes across sites

Assist in gathering requirements for improvements and ongoing maintenance by participating in meeting/workshops with Site Process Owners and business SMEs

Participate in additional user forums for gathering ongoing requirements and prioritization and triage issues

Follow-up on requests, issues, and projects and report statuses to manager/ working teams

Initiate and manage change controls, with associated documentation requirements, to completion

Ensure system is maintained in a validated state by participating in periodic user access review, ongoing change management, business administration, and deviations/CAPAs associated with Quality Systems

Support investigation, escalation, and resolution of issues identified on the system

Support validation activities as requested; this includes but is not limited requirements gathering, validation planning, design qualification, authoring test plans and test scripts, execution of test scripts, discrepancy management, and authoring system description and validation summary reports

Support manager with ongoing communication from vendor/IT where required

Provide customer support through system and training management and onboarding of new users

Generate metrics to support quality systems

Support regular system updates/ releases and provide assessment of and recommendations regarding new features

Maintain key user-related documentation and ensure it is kept up-to-date as new functionalities are enabled, created and/or modified

Qualification

Validation testingRegulatory ComplianceGAMP knowledgeUS FDA knowledgeICH Guidelines knowledgeCustomer supportChange managementDocumentation management

Required

Bachelor's degree or higher in relevant computer/technical/quality/scientific discipline, preferably multi-disciplinary with a strong technical and quality background

Minimum of 3-6 years of experience in a high volume commercial / clinical pharma / healthcare facility

Understanding and working knowledge of US FDA and European regulatory requirements and GAMP, and the ability to determine phase appropriate requirements

Knowledge of Regulatory Compliance and ICH Guidelines

Experience with validation testing required