Title: Quality Operations Specialist
Location: Princeton NJ
Duration: 09 months with possibility of extension
Shift: Mon -Fri 40 hours/week
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 o 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 o Follow-up with study teams on metrics responses o Follow-up with teams with Spot Check responses due, Follow-up on training due (based on Power BI 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.
Education:
Education/Experience/Skills: Bachelor's degree in Science or a related field. 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.