- Merck & Co. (Durham, NC)
- Job DescriptionThe Quality Control Senior Specialist plays a critical role in ensuring the quality of our products by managing laboratory data and overseeing ... external resources, when necessary, to support manufacturing processes.Responsibilities of the Quality Control Senior Specialist include leading routine testing… more
- Merck & Co. (Durham, NC)
- …events, or business support initiatives, as guided or approved by Quality management. Train employees on new or revised processes or procedures. Review and ... the network of life-saving medicines and vaccines. - The Associate Director, Quality Systems and Compliance provides expertise in the coordination of resources and… more
- Merck & Co. (Durham, NC)
- …skills). Attention to detail, flexibility and an awareness of production and attendant quality control problems. Basic understanding of GMPs and of regulatory ... detail, flexibility and an awareness of production and attendant quality control problems.Strong understanding of GMPs and...then your employment may pose an undue burden to business operations, in which case you may not be… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- … systems team, ad hoc, for activities such as annual product review, site risk register, or internal quality agreements. Develops and delivers training for ... promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Compliance Lead as part of the Quality team based in Raritan,… more
- Eisai, Inc (Nutley, NJ)
- …program, including JSOX compliance.Maintain accurate compliance documentation and advise control owners.Assess risk , evidence adequacy, and remediate ... governance and management.Certified Information System Manager (CISM), Certified in Risk and Information Systems Control (CRISC), Certified Information… more
- Merck & Co. (Rahway, NJ)
- …and development; manufacturing process development, qualification, and validation; and, design control and risk management techniques to positively support and ... tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with… more
- Aequor (Thousand Oaks, CA)
- …PQL has responsibility for working with PQ staff and executive leadership, International Quality , Quality Control , Contract Manufacturing Quality , ... regulatory requirements? Knowledge of analytical techniques used for protein molecule product quality control ? Understanding of drug substance and drug product… more
- Merck & Co. (Durham, NC)
- …written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) ... embraces an inclusive team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required.The HVAC&R Lead… more
- Merck & Co. (Rahway, NJ)
- … control systems to improve production efficiency and product quality .Collaborate with cross-functional teams, including operations, maintenance, and quality ... for optimizing and maintaining our manufacturing processes using process control systems and automation and operational technologies.Responsibilities:Assist in the… more
- Aequor (Thousand Oaks, CA)
- …them in a very detail oriented manner.Job Details: Owns and Manages Change Control Records. Owns and Manages Deviations, and Lead Root Cause Analysis. Develops, ... edits, and formats materials such as Standard Operating Procedures, Business Practices, forms, checklists, technical manuals, installation guides, user manuals,… more
- Catalent (St. Petersburg, FL)
- …with other functional areas (eg Product Development, Operations, Customer Service, Validation, Quality Control , etc.) to ensure continued compliance for the ... Manager may be dependent upon the needs of the business and structure of the Quality Unit...as QA in pharmaceutical industries. Prior experience working with quality control , manufacturing, product development preferred (Feasibility… more
- Merck & Co. (Durham, NC)
- …Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business )Adapt - Develop Our People, Culture and Business Model to ... maintaining accurate documentation of activitiesUndertaking SAP transactions and change control activities including spare part lists and preventative maintenance… more
- Insmed Incorporated (Bridgewater, NJ)
- …areas, in particular relating to Commercial practices of a US business .Understanding of compliance internal control concepts and framework.Maintains ... and engage with others, and find creative solutions to business challenges? Want to be a part of a...close-out of compliance issues and/or risks as identified by risk assessment and Monitoring and Auditing teamCollaborate with Compliance… more
- Aequor (Bothell, WA)
- …to ensure both systems and processes are DI compliant through governance and risk control , and drive mitigation/remediation actions when DI gaps are identified. ... Description: PURPOSE AND SCOPE OF POSITION: This position reports into the Quality Assurance department and is responsible for assisting with the implementation and… more
- Merck & Co. (Rahway, NJ)
- …launch.- The successful candidate will be responsible for resourcing planning, risk assessment strategies, talent development, and partnering to build a culture ... transfer to GxP laboratories.- He/she will be responsible for managing quality science and effective prioritization to bring analytical representation and expertise… more
- Merck & Co. (Rahway, NJ)
- …Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the ... accelerate process and product development and manufacturing and ensure safety and quality of our products. -The successful candidate will be accountable for… more
- Novo Nordisk Inc. (Durham, NC)
- …process control systems to meet current & projected customer, business & regulatory requirements through the following activities: People Focus, Equipment Focus ... Essential Functions Support plans to maintain & improve process control systems Schedule & execute plans in coordination with...improvement, & project management Operate within compliance with a Quality Mindset that focuses on risk management… more
- Merck & Co. (Rahway, NJ)
- …support several automation systems across the Rahway Site including ABB Distributed Control Systems, environmental control systems and equipment utility metering ... with key partners and area leadership to ensure delivery of business objectives, including operational efficiencies, compliance, energy savings initiatives, improved… more
- Novo Nordisk Inc. (West Lebanon, IN)
- … Quality Systems activities including Document Management system, Change Control , Deviations, and CAPA's Writing and/or revising procedures applicable to CSV ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...IT Systems, and Computerized Equipment's supporting Laboratories, Manufacturing, and Business Areas like Facilities and Warehousing Ensure that IT… more
