Roles and Responsibilities: 5+years of hands-on CSV in GxP environments. Experience with risk assessments, URS, IQ/OQ/PQ, deviations, reports. Knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q9, ALCOA+. Experience with...
Top Skills: Familiar with pharmaceutical master batch records and how to author CMC submissions for clinical studies. Technical writing skills Familiar with typical manufacturing processes, especially cell cultures Familiar with microbi...
Job Summary: The Sr. Design Quality Engineer is responsible for ensuring new or modified products conform to established quality standards and comply with the quality system. This role partners closely with cross-functional teams to prom...
Responsibilities: Convert specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs. Be responsible for overall project delivery, including clinical trial reports and other regulatory submission delivera...
Job Summary: The Senior Quality Specialist will be part of the Quality Assurance Department and will support Supplier Management activities at the Ridgefield site. This role is responsible for managing supplier-related quality processes, i...
Summary: The Senior Quality Specialist will be part of the Quality Assurance Department and will support Supplier Management activities at the Ridgefield site. This role is responsible for managing supplier-related quality processes, inclu...
Summary: Senior Process Engineer to support process and utility systems within a regulated biopharmaceutical manufacturing environment at our Holly Springs site. This role is fully onsite and requires strong hands-on technical expertise w...
successful 510(k) clearances and CE marking is required Strong understanding of medical device product life cycle and regulatory...
Job Summary: Manufacturing Project Manager responsible for leading, governing, and optimizing a diverse portfolio of strategic projects within a regulated medical device manufacturing environment. The role focuses on end-to-end project l...
Job Description: We are seeking a detail-oriented Field Action Remediation Specialist to implement remote software and firmware deployments, configure devices in RSS, and perform other remediation activities. This role requires deep techn...