- Merck & Co. (Durham, NC)
- …Care, Policy Development, Process Improvements, Quality Control Systems, Quality Management, Regulatory Compliance , Regulatory Documents, ... and/or review of required GMP documentation (Master Batch Records, change control , protocols, reports, qualifications, etc.) and regulatory filings.Provide… more
- Merck & Co. (North Wales, PA)
- …US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders ... and effective implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory Affairs, General Medicine… more
- Twist BioScience (South San Francisco, CA)
- …labeling, and SOP's. This role is crucial in supporting global product compliance , ensuring that all documentation accurately reflects regulatory requirements ... The Regulatory Operations Specialist is responsible for ensuring the...Data Sheets (SDS), SOP, and work instructions Familiarity with Quality Management Systems and electronic document control … more
- Aequor (Swiftwater, MN)
- OVERVIEW:This position supports the execution of routine testing in the Quality Control Analytical Chemistry laboratory, including chemistry assays associated ... with Incoming Quality and Raw Materials. This position requires proficiency and...Development, Validation, Independent Demand, and Stabilityprogram. Maintain safety and compliance of the laboratory work area. Perform cleaning of… more
- Merck & Co. (Rahway, NJ)
- …Quality Control , Manufacturing Scale-Up, Manufacturing Systems, Regulatory Compliance , Results-Oriented, Technology Transfer-Preferred Skills:Job Posting ... enhance data monitoring capabilities, and drive excellence in safety, compliance , supply, and productivity.Global Impact:Collaborate with colleagues across the US… more
- Merck & Co. (Rahway, NJ)
- … Control Management, Quality Management Systems (QMS), Quality Standards, Regulatory Requirements, Root Cause Analysis (RCA), Stakeholder Communications, ... meet deliverables and timelines.Preferred:Experience in pharmaceutical or related industry in quality control , quality assurance, manufacturing, clinical… more
- Aequor (Thousand Oaks, CA)
- …inspections preparation, planning, execution and response activities as well as facilitating compliance of compliance and regulatory requests Supports ... Continual Improvement initiatives, programs and projects Alerts management of quality , compliance , supply and safety risks Represents the quality management… more
- Tris Pharma (Monmouth Junction, NJ)
- …(CPIs)Works directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior ... Leadership, etc.) on deviations and PQC investigations relating to production operations, quality operations oversight and quality control analysis and… more
- Aldevron (Miami, FL)
- …implementation and maintenance of all Quality and release processes in compliance with all foreign and domestic regulatory and statutory requirements. This ... positive audit results.Serve as the site's primary contact with both customers and regulatory agencies regarding quality / compliance issues and Negotiate … more
- BioAgilytix (Durham, NC)
- …a foundational data governance framework, with hands-on responsibility for data quality , access control , and compliance protocols.Define standards, ... and rule-based checks to identify data discrepancies in real-time, enhancing regulatory compliance and minimizing errors.Independently design and configure basic… more
- Twist BioScience (South San Francisco, CA)
- …continuous improvement, technical excellence, robust software development practices, and regulatory compliance .Software Development & Implementation: Oversee the ... with data analytics tools and methodologies for process monitoring and quality control in biotech, including building custom reporting dashboards.About… more
- Merck & Co. (Durham, NC)
- …with optimized product quality and manufacturing processes and regulatory compliance .GENERAL PROFILEProvides leadership and direction through individual ... provides the best in class services with the final goal of delivering our high- quality vaccines to the patients around the world. With our core principle of Safety… more
- Merck & Co. (Millsboro, DE)
- …state regulatory requirements for animal welfare, management of controlled substances, quality control testing according to GMP standards, and emissions ... at our company's Millsboro Animal Health facilities. This role is highly compliance -driven in accordance with State and Federal regulations as applicable to the… more
- Aequor (Bothell, WA)
- …instrumentation as well as site and global applications used within the manufacturing, quality , and quality control organizations.This position requires a ... stakeholdersProvide local administrative support and liaise with global partners for site quality systems and quality control supporting applications,… more
- Merck & Co. (Rahway, NJ)
- …Problem Solving, Process Analytical Technology (PAT), Product Development, Professional Networking, Quality Standards, Regulatory Compliance , Regulatory ... Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our...as well as advancing a culture of scientific excellence, compliance mindset and collaboration with various partners and stakeholders… more
- Merck & Co. (Rahway, NJ)
- …clinical and scientific contacts and key opinion leaders in relevant fields.Conduct quality control inspections of study protocol, study documentation files and ... the Final Study Report Maintain contact with all stakeholders (project leader, regulatory affairs, quality assurance etc.) and keeps them informed of… more
- Merck & Co. (Durham, NC)
- …Relationships, Inventory Management, Management Process, Manufacturing Processes, Manufacturing Quality Control , Operational Excellence, People Management, ... a team of individual contributor production direct reports including safety, quality , and daily operations;Ensure that Shift(s) objectives are achieved while… more
- Merck & Co. (Rahway, NJ)
- …Data-Driven Decision Making, Drug Product Development, Estimation and Planning, GMP Compliance , Management Process, Manufacturing Quality Control , Medical ... selected candidate will lead and contribute to the launch and regulatory certification of the facility, concluding startup and operational readiness activities.Once… more
- Merck & Co. (South San Francisco, CA)
- …in developing, implementing, and optimizing GenAI approaches to streamline the creation and quality control (QC) of regulatory submission documents. The ... AI (GenAI) to enhance document authoring processes, thereby improving efficiency and compliance in regulatory submissions.The candidate will play a key role… more
- Merck & Co. (Rahway, NJ)
- …Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization ... and retaining diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and… more
