- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure cross functional integration and delivery of items (eCRF, EDC, IXRS, Quality Oversight Plan etc) per the study plan. Oversee the CRO and provide ... updated (eg Global Project Management System, GPMS). CRO and Quality Oversight:Responsible for management of CRO(s) performance to ensure...and site level documents to the Daiichi Sankyo Document Control Center (DCC) in support of the Trial master… more
- Merck & Co. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. POSITION OVERVIEW The successful… more
- Eisai, Inc (Nutley, NJ)
- …controls.Monitor and test IT compliance controls for effectiveness.Remediate control deficiencies and investigate potential unlawful actions.Oversee system data ... program, including JSOX compliance.Maintain accurate compliance documentation and advise control owners.Assess risk, evidence adequacy, and remediate findings.Evaluate new… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …playing a supportive role in ensuring adherence to Project objectives, budget control and departmental collaborations. Work is escalated if outside of scope of ... or safety. Basic understanding of professional working environment as well as Quality Assurance and global regulatory requirements such that identification of risks… more
- Novo Nordisk Inc. (West Lebanon, IN)
- … Quality Systems activities including Document Management system, Change Control , Deviations, and CAPA's Writing and/or revising procedures applicable to CSV ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...governance and continuous improvement as an enabler supporting product quality , patient safety, and data integrity, and contributes to… more
- Merck & Co. (Rahway, NJ)
- …and process audits, both domestic and abroad to maintain a strong internal control environment at our company.On occasion, the incumbent will be expected to lead ... papers (including walkthroughs and sample testing) in line with the established quality standards and timelines.Collaborate with the audit team in the writing of… more
- Merck & Co. (Rahway, NJ)
- …transfer to GxP laboratories.- He/she will be responsible for managing quality science and effective prioritization to bring analytical representation and expertise ... analytical techniques to solve problems, sound scientific understanding of Critical Quality Attributes and Quality by Design principles, and advanced… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …player in the Deviation Response Team team and a champion for quality priority principles and compliance within the organization. Relationships Reports to: According ... alone during regulatory inspection through close collaboration with Operations and Quality teams Lead cross-functional investigation teams to identify root cause,… more
- Minnesota Pollution Control Agency (St. Paul, MN)
- …/ Pollution Control -MAPE Division/Unit: Environmental Analysis & Outcomes / Water Quality Monitoring Unit Work Shift/Work Hours: Day Shift Days of Work: Monday - ... of professional experience conducting professional-level environmental protection or pollution control experience that includes water quality monitoring with… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …manufacturing operations. Focus areas may include Training, Documentation, Deviations, Change Control and Projects. Drives the coordination and execution of process ... and equipment improvement programs, reviews completed quality records, generates quality deviation responses, drive investigations and has ability to train… more
