Vacancy expired!
Business Analyst
CA, San Mateo 94404 Security Clearance: U.S. Citizen or Green Card Holder Skills: Veeva RIM, QMS, Regulatory Affairs, CMC, QA, Manufacturing OperationsWe are recruiting for multiple Business Analysts to work in a pharmaceutical manufacturing operations environment. Qualified candidates will have prior Veeva RIM Module experience. Prior experience facilitating user workshops is required. Location Note: The team is currently working remotely due to COVID-19 and will be located on-site once health precautions are lifted. Candidates must be located in the San Mateo - Foster City commuting area for consideration. Job Type: These positions are W2 consulting opportunities with hourly rate and no benefits. Direct corp-to-corp consultants will be considered. Role and responsibilities include:- Analyzing all aspects of ongoing state challenges that relate to regulatory affairs for Chemistry, Manufacturing, and Controls (CMC)and QA business processes
- Utilizing knowledge of Regulatory processes to develop future business processes for data entry related to planning, submission, and batch release
- Developing an approach to implement Product Docket/Regulatory Information Management packaged software
- Discovering areas of improvement across Regulatory, Supply Chain, and Quality business processes
- Developing metrics to monitor operational performance and authoring deliverables within the business process workstream
- Conducting workshops that document business processes focused on meeting corporate and regulatory CMC requirements
- U.S. citizen or Green Card Holder (sponsorship is not available for these positions)
- Currently located within commuting range and availability to work on-site after COVID-19 health restrictions are lifted
- 5-7 years of related experience with Regulatory Information Management systems
- Expertise in Veeva RIM and RIM products
- Experience with the Veeva RIM Registrations module and/or Veeva RIM/QMS implementation
- Bachelor's degree in a related discipline
- Experience with pharmaceutical and biotech manufacturing processes
- Thorough knowledge of clinical and commercial Regulatory process
- Experience with process improvement/process maps (SIPOCs) and managing performance metrics and KPIs
- Knowledge of Veeva RIM and/or RIM products is required
- Effective written and verbal communication skills to work in a collaborative environment
Vacancy expired!