Quality Management Specialist II

Quality Management Specialist II (2649-1)

The Quality Associate tasks include:

• CW shadows 3 ongoing studies and supports 7 ongoing studies (planning to reporting stage) to provide Quality oversight, to recommend best practices. Communicates and collaborates with the stakeholders (CM and FAs) partnering for cross-functional team support and attendance of project and study level meetings.
• With the assistance of Senior GCP Level 1 members, consults on major and critical quality issues, potential Serious Breaches, significant noncompliance, data integrity issues and protocol deviations, escalates to Senior Management, and performs periodic resolution checks for assigned studies.
• Supports risk assessments and risk-based approaches for the annual GQM Audit Plan, identifies the number of site audits and vendor audits based on risk-criteria with input from study teams. Provides study and site related information and documentation to the audit team, GCP Level 2 in preparation for audits.
• Participates in the risk assessment of preferred and active vendors utilizing risk assessment tools to prepare the annual GQM Vendor Audit Plan.
• Involved in CAPA review of Quality Issues, Audits, Inspections, eTMF audit responses.
• Participates and contributes to weekly, monthly, and quarterly GQM GCP meetings.
• Attends QA:
  
  QA and Quality Council meetings with CRO accompanied by a Senior Member from the GCP In-Line Quality (Level
  1).
• Participates in the review and harmonization process of controlled documents such as protocols/ICF, CSRs, amendments, procedural documents & templates.
• Receives GCP training of ICH Guidelines E6 R3 and Modules from 21
  
  CFR and reads GCP Material. Team Members in training participate in weekly team support meetings.
• Involved in the Portfolio-wide proactive Inspection Readiness support (Sponsor, Site, CRO) - conducts Do & Don’t training, participates in interview preparations/debriefs, assesses Inspection Readiness Visits and Pre-Inspection Visits outcomes.
• Reviews and assesses Pharmacovigilance System Master File (PSMF) and performs PV related activities as assigned.

Bachelors Degree; preferably some Pharmaceutical background and GCP ICH E6 knowledge.

Full‑time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

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• Seniority level:
  Entry level
• Employment type:
  
  Contract
• Job function:
  Quality Assurance