Quality Systems Specialist - Pharmaceutical

We are looking for a Quality Systems Specialist to join our pharmaceutical team in Waltham, Mass! This is a hybrid position with onsite days as Tuesday, Wednesday and Thursday.

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

6 month contract plus extension

REQUIRED QUALIFICATIONS:

• 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
• 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, andthe ability to determine phase appropriate requirements
• Knowledge of Regulatory Compliance and ICH Guidelines

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
  

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.