Overview
Quality Associate I- #26-17180 Jobs in Princeton, NJ at US Tech Solutions
Title: Quality Associate I- #26-17180
Company: US Tech Solutions
Location: Princeton, NJ
Duration: 12+ Months
Description:
The Quality Associate tasks include:
- Supports multiple 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 Global Quality Management (GQM) Study Oversight & Inspection Readiness 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, Audit Management 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 Audit Management team.
- 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 and compares Inspection Readiness Visit and Pre-Inspection Visit findings.
- Reviews and assesses Pharmacovigilance System Master File (PSMF) and performs PV related activities as assigned.
Qualifications:
- Minimum of Bachelor’s degree in life science or related
- Quality related training and/or certifications (ie Root Cause Analysis (RCA), Good Clinical Practice (GCP)) required
- Experience in pharmaceutical industry, biotech or CROs with experience in clinical quality assurance or GxP compliance, clinical trial operations, and/or regulatory affairs
- Strong knowledge of ICH GCP, health authority regulations, and global clinical trial requirements
- Strong attention to detail
- Ability to analyze data, identify trends and perform Root Cause Analysis (RCA)
- Assist in finding solutions to quality issues and support process improvements
- Strong ability to clearly and concisely document findings and communicate with different functional areas
- Work collaboratively with team members, including quality associates and quality leaders, and functional team leaders
- Willingness to adapt to new technologies and process as the global quality team evolves
- Experience in TrackWise or similar QMS platforms is preferred
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, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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