- Merck & Co. (Rahway, NJ)
- …guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal ... in Biologics Cell Culture Sciences group and working in conjunction with internal and external partners, this individual will support late stage and commercial… more
- Merck & Co. (Rahway, NJ)
- …audits and process audits, both domestic and abroad to maintain a strong internal control environment at our company.On occasion, the incumbent will be ... (IT) Systems, Information Technology Auditing, Internal Audit Development, Internal Auditing, Internal Control Testing, Interpersonal Relationships,… more
- Merck & Co. (Ames, IA)
- …of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an ... across the globe.Position Description:The Site Quality Head directs the Quality and Compliance activities at the Site, provides support and expertise in these areas,… more
- Merck & Co. (North Wales, PA)
- …Equipment team, in providing technical leadership and support to our company's internal & external packaging network, focusing on developing and executing packaging ... processes including packaging equipment design & development, ensuring packaging process control and efficiency and providing on-going packaging and device technical… more
- Merck & Co. (Rahway, NJ)
- …with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Utilize extensive experience in design controls, ... device transfer, control strategies, device risk management, and design verification testing to develop value-added solutions for medical devices and combination… more
- Merck & Co. (Rahway, NJ)
- …and campus planning?- Have you advised on design standards, project scope, and regulatory compliance as well as act as a liaison with internal department ... ensuring alignment with Our Company's strategic goals.Develop liaisons with internal departments and community organizations to gather input and facilitate… more
- Merck & Co. (Rahway, NJ)
- …and compliance of our company's product portfolio across the internal and external networksThe candidate is expected to build inclusive, collaborative ... partnerships with internal and external stakeholders, such as packaging and manufacturing...achieved and ensure filings with regulatory bodies to ensure compliance with relevant regulations and standards.-- Ensure thorough engineering,… more
- Merck & Co. (Rahway, NJ)
- …and compliance of our company's product portfolio across the internal and external networksThe candidate is expected to build inclusive, collaborative ... partnerships with internal and external stakeholders, such as packaging and manufacturing...achieved and ensure filings with regulatory bodies to ensure compliance with relevant regulations and standards.-- Ensure thorough engineering,… more
- Merck & Co. (Rahway, NJ)
- …the successful completion of projects. This includes technical support to the internal and external manufacturing sites as well as Third Party Logistics providers ... systems.-The candidate is expected to build inclusive, collaborative partnerships with internal and external stakeholders, such as packaging and 3rd party logistics… more
- Tris Pharma (Monmouth Junction, NJ)
- …in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/Regulatory Affairs, including reviews/approvals of Change Control ... well as test methods and proceduresPrepares CCRs, according to change control processCoordinates, advances and monitors progress for all required documentations and… more
- Tris Pharma (Monmouth Junction, NJ)
- …supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and other company and regulatory agency ... procurement policies and procedures throughout the organization. Ensures compliance with all current GxPs, Food and Drug Administration (FDA), Drug Enforcement… more
- Merck & Co. (Rahway, NJ)
- …industry.Required Experience and Skills: Strong background in integrated analytical control strategy development and execution. Demonstrated ability to lead a ... knowledge and experience with regulatory guidance and industrial standards of control strategy for residual HCPs and other process related impurities in… more
- Merck & Co. (Baton Rouge, LA)
- …annual appraisals, individual development plans and succession planning.Evaluates the internal performance for all aspects of production and fulfillment operations ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …proper materials, parts and spare parts are identified and availableSupports team compliance to Lock Out/Tag Out programs, Hot Work permits, confined space entry ... Quality driven initiatives related to facilities work such as change control , deviation, and corrective actions.Ensure collaboration with key stakeholders and… more
- Aequor (Thousand Oaks, CA)
- …controlled documents to ensure compliance with regulatory standards and internal quality procedures. This role emphasizes quality control , template ... adherence, and milestone tracking. The lead works closely with stakeholders to coordinate document workflows, perform rigorous QC reviews, and ensure timely and accurate completion of documentation deliverables within the electronic document management system. more
- Merck & Co. (Rahway, NJ)
- …molecular biology and immunoassay techniques - Strong background in ana lyt ical control st r ategy development and execution - Demonstrated ability to develop ... assay optimization and documentation to meet program deadlines. - Authoring and reviewing internal technical reports, sections of regulatory filings ( eg, IND , BLA… more
- Repligen (Clifton Park, NY)
- …timely delivery and stakeholder alignment.Oversee contractors/vendors and ensure compliance with safety, quality, and operational standards.Support quality systems ... or project teams.Strong problem-solving skills with mechanical, electrical, and control systems (motors, drives, sensors, packaging lines).Skilled in troubleshooting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …pharmaceutical environment with adherence to strict regulatory guidelines and internal compliance policies.In depth understanding of cleanroom manufacturing, ... to IQ/OQ/PQ, EMPQ, APS, PPQ, preferred.Experience with change management/change control and quality systems.Experience with FMEA and risk assessment tools.Experience… more
- Merck & Co. (Rahway, NJ)
- …work in a matrixed team environment and collaborate with both internal and external partners including vendorsKnowledge of biologics CMC development ... using automation platforms such as TECANExperience using and/or programming process control systems such as DeltaV and PCS 7Experience with integrated and… more
- Monster (Tulsa, OK)
- …organization. This role plays a key part in strengthening the organization's control environment by conducting risk-based audits, evaluating compliance , and ... internal audits across the organization. Evaluate the effectiveness of internal controls, policies, and compliance with regulations. Prepare detailed audit… more
