Quality Control Specialist

Required

• B.S. in chemistry, biology, quality management, engineering, or related discipline preferred.
• 2+ years experience in the area of quality assurance/control, process engineering, and/or product formulation
• Experience within a 503b outsourcing facility Aseptic processing experience and knowledge of ISO 14644 Working knowledge of USP-NF standards , , including monographs Experience in cGMP or regulated environment with knowledge of FDA 21, CFR 210, and 211 a plus Excellent interpersonal skills and communication skills (verbal and written)
• Solid understanding of product testing including understanding best practices for testing product against defined specifications
• Ability to multi-task and work independently.
• Highly motivated self-starter. Solid computer skills with Word, Excel, Visio, PowerPoint, and Outlook. MRP, Excellent skills in decision making, data collection and analysis, organizing and planning.
• Working knowledge and application of statistical analysis including probability and trend analysis Knowledge and experience in technical writing Knowledge and experience in Auditing
• Some travel may be required