- Merck & Co. (Rahway, NJ)
- …GMP documents. Ensure all API are manufactured in compliance with cGMP and regulatory filings. Perform independent quality review and approval of batch records, ... communications with all stakeholders in all manufacturing operations, analytical testing, quality assurance, regulatory , etc. at all levels. Establish, educate,… more
- Insmed Incorporated (San Diego, CA)
- …Director of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality ... (Essential Role Responsibilities):Establish and maintain a risk-based and scientific-based quality system to support GCP.Oversee regulatory agency inspections… more
- Repligen (Waltham, MA)
- …manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate cross-functional teams to assess and mitigate ... supporting root cause investigations, and ensuring Repligen's supplier network meets regulatory and quality standards. This role is based in Waltham, MA, and… more
- Merck & Co. (Rahway, NJ)
- …( our Manufacturing Division / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of ... of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional… more
- Merck & Co. (Rahway, NJ)
- …requirements for CMC.- Strong understanding of integration and partnering with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Collaborate with key stakeholders across the organizations (Research… more
- Merck & Co. (Rahway, NJ)
- …particularly in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.The incumbent ... set tactical and strategic direction on programs to ensure delivery of high- quality products, test methods, and robust manufacturing processes for both clinical and… more
- Formation Bio (New York, NY)
- …role in scaling our biologics capabilities in partnership with technical, quality , and regulatory leaders.Responsibilities Strategic Leadership Develop and ... Collaboration & External Partnerships Partner closely with analytical development, manufacturing, quality , and regulatory teams to ensure seamless execution of… more
- Merck & Co. (Rahway, NJ)
- …to: Lead and oversee analytical investigations with a strong focus on quality and regulatory compliance.Excel in impurity isolation, unknown peak identification, ... leadership and collaboration.Maintain a deep understanding of the regional regulatory and business environment, including:API and Drug Product development needsGMP… more
- Aequor (Hicksville, OH)
- …employees. Adheres to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, ... components/finished goods. Performs packaging line assignment maintaining line throughput and quality standards. Contributes to the team by supporting other lines… more
- Aequor (Hicksville, OH)
- …employees. Adheres to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, ... safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality… more
- Aequor (Hicksville, OH)
- …occur. Adheres to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, ... to service multiple packaging lines simultaneously. Alerts Supervision, Mechanics and Quality personnel of safety, quality and equipment performance problems… more
- BioAgilytix (Durham, NC)
- …tools that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a ... at diagnosing data challenges and designing innovative solutions to improve data quality , integration, and regulatory adherence.Capable of growing with the role… more
- Aequor (Thousand Oaks, CA)
- …to peers and senior leadership team. Additional Responsibilities include: Engaging with Quality and Regulatory teams to ensure alignment and compliance across ... to add value to the network: Manufacturing, Process Development, Supply Chain, Quality , and Facilities & Engineering. A high degree of interactions and collaboration… more
- Merck & Co. (Rahway, NJ)
- …Strategies, Outsourcing, Process Improvements, Production Scheduling, Project Management Planning, Quality Compliance, Regulatory Compliance {+ 3 more}-Preferred ... functional representatives, is responsible for ensuring the reliable supply of quality products at competitive costs from external manufacturing partners (EPs) and… more
- Tris Pharma (Monmouth Junction, NJ)
- …coordinates and advances required documentations, in liaison with Product Development (PD)/ Quality Assurance (QA)/ Quality Control (QC)/ Regulatory Affairs, ... required documentations and change control activities, in liaison with PD/QA/QC/ Regulatory AffairsDesigns experimental plans; Critically analyzes data and information… more
- Twist BioScience (South San Francisco, CA)
- …by collecting, analyzing, and summarizing information and trendsWrite/review product quality documentationFollow regulatory and ISO 13485 requirementsWhat You'll ... He/she will work closely with the operations team to monitor the quality of Twist DNA products utilizing quantitative measurements, fragment analysis, NGS… more
- Insmed Incorporated (San Diego, CA)
- …for trend analysis are also key duties. Collaboration with R&D, Process Development, Quality Control, and Regulatory Affairs is essential, as is facilitating ... technical issues. Contributes to method qualification and validation according to regulatory guidelines such as ICH, FDA, and cGMP, evaluating method characteristics… more
- Merck & Co. (Rahway, NJ)
- …Metrology Equipment, Personal Initiative, Pharmaceutical Management, Pharmacy Regulation, Quality Auditing, Regulatory Compliance, Reviewing Literature {+ ... of the integrated US Metrology and Validation team and drive a culture of quality and operational excellence across the global AR&D network. The role oversees and… more
- Aequor (Hicksville, OH)
- …assigned Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ... in a timely manner, observing all safety regulations and ensuring all cGMP and quality standards are met and to maintain the efficient flow of product through the… more
- Eisai, Inc (Exton, PA)
- …will collaborate effectively with other Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program ... close-out reports for Biologics Pilot Plant campaigns. Support providing data for regulatory documents as required.7. Ensure adherence of operations to cGMP, ICH,… more
