Quality System Specialist

Peak Performers has partnered with a global pharmaceutical company to assist in their search for a hybrid Quality System Specialist in Waltham, MA. 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.

• 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

• 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

• Rate: $50.00/hour
• W2 Contract
• Worksite
  
  Location:
  
  Waltham, MA
• Hybrid
• Contract Length: 6 month contract

• Excellent medical health, dental & vision insurance at 60 days
• Our employees may choose to participate in a 403(b) retirement plan
• Qualified applicants with chronic medical conditions and/or disabilities receive priority placement
• We pay weekly through direct deposit
• In business since 1994 and thousands of job placements

All employment offers are contingent on the successful completion of a pre‑employment criminal background check, in compliance with all applicable federal and state laws.

Applicants for employment with Peak Performers must possess work authorization that does not require sponsorship for a visa now or in the future.

Peak Performers is an equal opportunity employer and will consider all applicants without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law. Peak Performers does not accept unsolicited resumes from headhunters, recruitment agencies or fee‑based recruitment services.

• Mid-Senior level

• Contract

• Quality Assurance

• Staffing and Recruiting