- Merck & Co. (Durham, NC)
- …patients on time, every time, across the globe. The main function of the Associate Specialist, Quality Control is to assist in the assurance of the quality ... LIMS, SAP or other laboratory/production software systemsWorking RelationshipsReports to Quality Control managerInteracts with employees within own department… more
- Merck & Co. (Rahway, NJ)
- …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...Validation, Independent Demand, and Stability program. Maintain safety and compliance of the laboratory work area. Perform cleaning of… more
- Merck & Co. (Rahway, NJ)
- …(QMS), Quality Metrics, Regulatory Compliance , Regulatory Inspections, Vaccine Manufacturing-Preferred Skills: Quality Control Reviews, ... Corrective and Preventive Action (CAPA), Detail-Oriented, Driving Continuous Improvement, GMP Compliance , Manufacturing, Pharmaceutical Quality Control (QC),… 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
- Merck & Co. (Rahway, NJ)
- …for sustained launch in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Strategic ... and performance of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance:Ensure that all… 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
- Merck & Co. (Rahway, NJ)
- …Making, Detail-Oriented, Maintenance Supervision, Manufacturing Process Validation, Manufacturing Quality Control , Manufacturing Scale-Up, People Management, ... characterization (PC), process performance qualification (PPQ), risk assessment (RA), control strategy, process comparability reports, and/or regulatory … 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
- Community Health Systems (Springdale, AR)
- …within an assigned section of the laboratory. This role oversees testing accuracy, quality control , regulatory compliance , equipment maintenance, ... and workflow optimization. Strong understanding of quality control , proficiency testing, and regulatory compliance... quality control , proficiency testing, and regulatory compliance requirements (CAP, CLIA, Joint Commission).… 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
- Insmed Incorporated (San Diego, CA)
- …Department, supporting clinical GMP drug substance and drug product production and quality control operations. This role combines technical leadership in ... of calibration and maintenance systems to ensure operational readiness and regulatory compliance . Responsibilities include leading the procurement, installation,… 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
- 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)
- …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
- Aequor (Thousand Oaks, CA)
- …senior leadership team. Additional Responsibilities include: Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network ... of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting… more
- Insmed Incorporated (San Diego, CA)
- …software for trend analysis are also key duties. Collaboration with R&D, Process Development, Quality Control , and Regulatory Affairs is essential, as is ... transfers and mentoring junior staff. Maintaining laboratory equipment, ensuring safety and regulatory compliance , and supporting audits are also part of the… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... relevant processes. Ensures alignment of training processes to corporate & quality systems. Responsible for maintaining Standard Operational Procedures (SOPs) for… more
