- Tris Pharma (Monmouth Junction, NJ)
- …guidelines, standards and objectiveOversees and manages maintenance and tracking of Quality Systems including, but not limited to: Investigations/OOS/OOT/Lab ... and product quality complaintsEngages in activities to continuously assess/improve quality systems by identifying and proactively resolving quality … more
- Cepheid (Miami, FL)
- …the Danaher Business System which makes everything possible.The Senior Quality Systems Specialist is responsible for functioning as Lead Internal Auditor to ... improvements. This position will work with the Senior Manager Quality Systems Compliance.This position is part of...this role, you will have the opportunity to:Function as Lead Auditor to schedule, plan, perform, and document internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaboration with Audits Compliance team, determine relevant audit targets for GxP computerized systems for consistency.A seasoned quality leader with the ... standards are met.Proactively assess and address operational gaps related to quality systems and compliance, fostering a culture of sustainable… more
- Novo Nordisk Inc. (Durham, NC)
- …preferably in the pharmaceutical industry Demonstrated expertise in Regulations & quality systems (eg, commercial product disposition, DV/CAPA, Change Control, ... processes. Relationships Reports to Manager, QA. Essential Functions Ensure plant systems batch release & relevant quality processes are compliant with… more
- Aequor (Thousand Oaks, CA)
- …change requests approved by management. 4. Work within the Information Services and Quality Systems teams to foster good communication throughout the project ... possible remote role Summary: Under general direction, functions as the Specialist Quality Control working at the Corporate QC Center. Description: Job Details:… more
- Eisai, Inc (New York, NY)
- …The Software Developer Validation Quality Professional will work closely with the quality assurance clinical systems lead to deliver on internal ... Validation Quality Professional l will work closely with the quality assurance clinical systems lead to deliver on internal validation efforts and audits… more
- Aequor (Thousand Oaks, CA)
- …Drug Product Formulation and Vial/Syringe Filling operations Experience with various quality systems including change control, deviations, corrective and ... Lead within the New Product Introduction, Manufacturing Execution Systems , and Digital team at ATO B20. The NPI...value to the network: Manufacturing, Process Development, Supply Chain, Quality , and Facilities & Engineering. A high degree of… more
- Merck & Co. (Rahway, NJ)
- …Procurement, Product Development, Product Lifecycle Management (PLM), Product Risk Management, Quality Management Systems (QMS), Risk Management, Root Cause ... projects, including those related to Combination Products and Drug Delivery Systems . The role includes leading, enabling or consulting in the development… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …help the team, in a manner consistent with safety policies, quality systems , and cGMP requirements.Support manufacturing investigations, create/revise ... a team-based environment, on an assigned production shift schedule.Key Responsibilities Lead and supervise multiple units within the CAR-T process operations (ie… more
- Merck & Co. (Rahway, NJ)
- …and supporting quality investigations and change management and experience with quality systems also required.Must have knowledge and experience of drug ... Job DescriptionResponsibilities Serve as a leader in the Formulation, Laboratory, and Experimentation (FLEx) Sterile GMP Clinical Manufacturing facility.Contribute… more
