- Merck & Co. (North Wales, PA)
- Job DescriptionThe Senior Specialist, Quality Management Systems and Compliance reports to the Director, Animal Health Quality Management Systems ... Recall, and Health Authority Notification processes, and participate in additional Quality Systems improvement projects and compliance initiatives.Primary… more
- Catalent (San Diego, CA)
- …5 years' experience in QA/Regulatory Affairs areas with progressive responsibilities for quality metrics, quality systems , deviations, investigations, CAPAs ... Senior Manager, Quality AssurancePosition Summary:Catalent Pharma...forms.Must have a demonstrable record of implementing and maintaining quality systems ; laying out a strategic plan… more
- Aequor (Thousand Oaks, CA)
- …and Engineering staff in the execution of their processes, procedures, and use of quality systems . Duties include but are not limited to: Purposeful presence on ... of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area… more
- Merck & Co. (Rahway, NJ)
- …improvement projects, and the automation system assets spanning production, utility systems and associated infrastructure.- Responsibilities of the Senior ... to prepare Standard Operating Procedures (SOP) and cGMP documents.Experience with Quality SystemsExperience in supporting compliance investigations and change… more
- Merck & Co. (Durham, NC)
- …preventative maintenance (PM) plans/calibration procedures, task lists, etc., as required.Work compliance systems for maintaining PM program and assessing ... Job DescriptionPosition Description: Senior Technician, MaintenanceThe Senior Maintenance Technician is responsible for providing equipment troubleshooting and… more
- Aequor (Thousand Oaks, CA)
- …Engineering areas/staff in the execution of their processes, procedures, and use of quality systems . Duties include purposeful presence on the floor, electronic ... documentation and operations according to company procedures. Experience working with Quality Systems , Strong organizational skills and ability to manage… more
- Merck & Co. (Durham, NC)
- …/ automation issues to improve manufacturing performance, and maintaining the automation systems in compliance with cGMPs. The Manufacturing Automation Sr. ... and embrace an empowered team culture including significant interaction with manufacturing, quality , IT, and engineering groups. - The Senior Specialist for… more
- Merck & Co. (Rahway, NJ)
- …attention to detail in completing GMP documentation, proficiency in electronic systems , and participation in continuous improvement projects.- Positions may also ... closely with team members and partner groups including formulators, engineers, Quality , Safety, and Facilities management to drive overall success and performance… more
- Merck & Co. (Durham, NC)
- …equipment performance, and assist in writing maintenance/calibration work instructions. The Senior Calibration Technician will use computerized systems such as ... within the site is seeking a highly motivated individual for a Senior Calibration Technician position. This individual will partner with Maintenance management, and… more
- Tris Pharma (Monmouth Junction, NJ)
- …standards and objectivesOversee and manage the maintenance and tracking of Quality Systems including, but not limited to Investigations/OOS/OOT/Lab Event, ... incumbent uses systems thinking and a holistic systems -based approach to drive compliance and assess... complaintsEngages in activities to continuously assess and improve quality systems by identifying and proactively resolving… more
- Merck & Co. (Rahway, NJ)
- …(including walkthroughs and sample testing) in line with the established quality standards and timelines.Conduct IT policy compliance , system implementation, ... Client Audit Director ("CAD") and the Auditor-in-Charge ("AIC"), the Senior Specialist will:Participate in the execution of IT internal...of duties with the highest level of integrity and quality . Show good judgment in the conduct of work.Position… more
- Catalent (Harman, WV)
- Position Summary The Director, Quality Systems is responsible for the management and oversight of the core quality systems , including ... , audits and inspections, raw materials release, and compiling, trending and reporting key quality metrics for Senior Management review, and other quality … more
- Novo Nordisk Inc. (Boulder, CO)
- …Boston R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new ... you ready to make a difference? The Position The Senior IT Engineer I - Labs will be responsible...Major tasks will include implementing and maintaining existing laboratory systems and instruments, enabling solutions for capturing data from… more
- Merck & Co. (Rahway, NJ)
- …scientists in experimental design, execution, and data interpretation Safety and Compliance Contribute to a safe and compliant laboratory work environment.MINIMUM ... protein biochemistry, biophysics, conjugation techniquesVector construction, Genetic Engineering, and Systems BiologyKnowledge of cell-line development for protein expression in… more
- Novo Nordisk Inc. (Boulder, CO)
- …& other validation activities Review & approve validation procedures, specifications & quality documents for accuracy & compliance Presentation & support for ... discipline experience in pharmaceutical or medical device industry required Experience in quality concepts including technical & compliance review of validation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personal development. Are you ready to realize your potential? The Position The Senior Application Architect leads the team of skilled technical experts to design, ... Work closely with cross-functional teams to integrate AEM with other enterprise systems and third-party applications Lead the design and architecture of required AEM… more
- Merck & Co. (North Wales, PA)
- …data management conceptsExperience in CDISC and ADaM standardsExperience ensuring process compliance and deliverable quality .Strategic thinking - ability to turn ... stakeholder requirements.Preferred Experience: Demonstrated success in the assurance of deliverable quality and process compliance . Strong working knowledge of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Reviews of respective product profile to ensure appropriate management review of all quality and compliance related topics including the review of Key ... Quality Indicators (KQIs). Identify appropriate continuous improvement initiatives for quality and compliance related areas. Deputize for the Head of RD QA at… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …matter expert on GxP compliance . He/she will also serve as key customer-facing senior quality leader to ensure the full alignment between customers and Exela ... of quality systems to ensure product reliability, quality , efficacy, and complianceOversee compliance auditing program to fulfill regulatory… more
- Insmed Incorporated (Bridgewater, NJ)
- …as well as reviewing and tracking CAPAs.Broad knowledge of risk-based quality systems approaches consistent with post-marketing Good Pharmacovigilance Practices ... Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA… more
