Title: Quality Specialist- Clinical Operations
Location: Princeton, NJ
Duration:10+ months
REMARK:
- Manager is seeing someone with STRONG soft skills in good and proactive communication, who can communicate with multiple sectors of the business to politely push them forward and meet quality deadlines. It cannot be someone's first role in pharma or clinical operations but does not need to have extensive experience as long as the detail oriented, project management, and communication proficiency is high.
- Targeting 1-3 years of progressively responsible experience within the pharmaceutical or biotech industry, including 1 year in Quality and/or Clinical Operations or other R&D function. An equivalent combination of relevant education and experience may be considered.
Position Summary:
- Responsible for assigned operational Quality Risk and Compliance (QRC) activities supporting Research and Development (R&D) quality efforts, including support of inspection readiness (IR), process improvement, quality metrics, and other assigned duties.
- Candidate will be required to work closely with internal R&D teams across all departments such as Clinical Development, Clinical Operations, Biometrics, Regulatory Affairs, Drug Safety and Pharmacovigilance, Translational Sciences, Program Management, and Medical Affairs.
Primary Duties and Responsibilities:
- Inspection Readiness (IR) Support Tracking and closure of IR actions across multiple parallel workstreams, assist with meeting minutes, scheduling of meetings, trainings, etc.
- Manage updates to Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP), Good Manufacturing Practices (GMP) SME Lists for Inspections, Follow-up on mock inspection Corrective and Preventive Actions (CAPA) closure and completion of lessons learned.
- Quality Metrics Support: Follow-up with study teams on metrics responses.
- Follow-up with teams with Spot Check responses due.
- Follow-up on training due (based on PowerBI compliance metrics).
- Pull raw data from systems for metrics generation as requested.
- Other Quality Operations Support: Follow ups for process improvement program.
- Budget/invoice tracking for QRC, tracking of new and revised controlled documents - follow ups with curricula owners on training changes, processing of Adobe Forms.
- Scheduling of quality related training workshops & Other internal meeting scheduling, minute taking, action item follow-ups as needed.
- Other duties as assigned/required.
- Proficient computer skills, including Microsoft Word, PowerPoint and Excel.
- Power BI experience a plus
Education:
- Bachelor's degree in science or a related field.