Quality Auditor - Scientific Ii - Hybrid Role - 3 Days Onsite -- Rahway, Nj

On-Board Scientific is hiring a Quality Auditor – Scientific II (Hybrid – onsite 3 days a week) in Rahway, NJ!
For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position Title and State you are Located

• Perform independent quality review and approval of batch records, testing data, and related documents required to release or reject product. Make independent batch release or reject decisions.
• Conduct independent auditing, review, and approval of diverse and complex document types, as required, including deviations, investigations, analytical method validations, method transfers, analytical methods, specifications, certificates of analysis, etc.
• Collect, prepare, and analyze data to support quality system metrics and planning.
• Perform document management activities such as cataloging records for long term document storage according to retention policies.
• Support compliance activities such as site readiness, audits, and CAPAs.
• Support quality risk management activities.
• Support projects for continuous quality improvement. Utilize project management skills as needed.
• Provide meeting coordination, facilitation, scribing, and communication.
• Develop, write, technical edit, or review procedures or other standards documents under GMP.
• Other duties as assigned by manager for the flexible functioning of the work group.

• Bachelor degree (B.S.) in an appropriate Science or Engineering discipline (engineering, chemistry, biology, biochemistry, microbiology). Minimum of 1 year experience preferred. Recent graduate can be considered.

Qualifications:<>•Experience should be in the pharmaceutical, biotechnology, chemical, medical device, or closely related industry. <>•Knowledge of R&D or clinical supply areas and processes. <>•Preferred API knowledge and experience.<>•Experience in one or more functional areas such as quality control, quality assurance, laboratory, manufacturing, production, equipment/facilities management, regulatory. <>•Good Manufacturing Practice (GMP) or related drug regulation knowledge and expertise. <>•Strong leadership, collaboration, teamwork, negotiation, communication, and workload management skills. <>•Ability to work in a dynamic R&D environment with rapidly changing needs. <>•Demonstrated ability to manage projects, priorities, to meet deliverables and timelines. <>•Ability to work across functional and sites, with all levels of staff and management.<>•Qualified candidates should have proficiency with Microsoft Suite (Word, Excel, PowerPoint, Teams, etc.) and ability to adapt to learning other electronic systems to support day-to-day work.<>•Fully onsite during training period, transitioning to Hybrid role requiring 3 days onsite a week.