Quality Management Specialist II

5 days ago

Princeton, United States US Tech Solutions Full time

Duration: 12 months The Quality Management Specialist II 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 21CFR 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.Qualifications: Bachelors Degree; preferably some Pharmaceutical background and GCP ICH E6 knowledge.About US Tech Solutions:US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.Recruiter Details:Name: VickyEmail: vicky.kumar@ustechsolutionsinc.comInternal Id: 25-54443

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