Quality Systems Specialist

Planet Pharma; Waltham (MA); On-site; USD 55,104 - 68,880; Full time

Job summary

A leading pharmaceutical company seeks a Quality System Specialist to support global Quality Systems and ensure compliance with applicable SOPs. Responsibilities include managing Quality System applications, gathering user requirements, and supporting system validation activities. The ideal candidate holds a Bachelor’s degree in a relevant field and has 3-6 years of experience in commercial/clinical pharma environments. Proficiency in MS Word and Excel is essential, with knowledge of Veeva Vault and similar tools desirable. This full-time role is based in Waltham, MA.

Qualifications

• 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.
• Knowledge of Regulatory Compliance and ICH Guidelines.

Responsibilities

• Support global Quality Systems ensuring compliance with SOPs.
• Assist in governance of Quality System applications and process harmonization.
• Participate in meetings/workshops for requirements gathering.
• Manage change controls and documentation requirements.
• Support validation activities, including test plans and scripts.

Skills

Quality System processes

MS Word

MS Excel

Education

Bachelor’s degree or higher in a relevant field

Tools

Veeva Vault Quality Docs

TrackWise

ComplianceWire

Job description

Quality System Specialist

Pay is commiserated with experience and ranges between $40-50/hr.

Key Areas of Job Accountability

• The Quality System Specialist, under the direction of the QS&C management team, will support the global Quality Systems and their operations in ensuring compliance and fit for intended use in accordance with applicable global SOPs.

Position Details

• 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 meetings/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 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.

Academic/Technical Qualifications

• Bachelor’s degree or higher in a relevant computer/technical/quality/scientific discipline, preferably multidisciplinary with a strong technical and quality background.
• Minimum of 3-6 years of experience in a high volume commercial/clinical pharma/healthcare facility.
• Proficient in MS Word, Excel, and Quality System processes. Experience with Veeva Vault Quality Docs, TrackWise, and ComplianceWire is a plus.
• Understanding and working knowledge of US FDA and European regulatory requirements and GAMP, and ability to determine phase‑appropriate requirements.
• Knowledge of Regulatory Compliance and ICH Guidelines.

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Location: Westborough, MA

Employment Type: Full-time

Seniority Level: Not Applicable

Job Function: Quality Assurance

Industries: Staffing and Recruiting