- Formation Bio (New York, NY)
- …authority audits.Responsibilities Develop, implement, and maintain the pharmaceutical quality management system (QMS) to ensure compliance with regulatory ... and documentation to ensure the consistent production of safe, effective, and high- quality pharmaceutical products. Lead internal and external audits to assess… more
- Tris Pharma (Monmouth Junction, NJ)
- …science or related field and minimum 6 years quality and/or cGMP compliance experience in the pharmaceutical or biotechnology industry in positions of ... and Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality … more
- Novo Nordisk Inc. (Durham, NC)
- …processes & functions in Department Quality Risk Management Make decisions on quality & compliance issues with little guidance Participate in process group ... of standards within the assigned process Provide coaching to Site regarding quality & compliance related activities Facilitate sharing of regulatory &… more
- Novo Nordisk Inc. (Durham, NC)
- …processes & functions in Department Quality Risk Management Makes decisions on quality & compliance issues with little guidance Participates in process group ... of standards within the assigned process Provides coaching to Site regarding quality & compliance related activities Facilitates sharing of regulatory &… more
- Novo Nordisk Inc. (Durham, NC)
- …& QA presence & process confirmation on shop floor. Relationships Manager, Quality Assurance. Essential Functions Ensure site compliance with Regulations, ... our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … team members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead(s) (GQLs) and Regional Quality ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...strategic priorities, by reviewing and monitoring the status of Quality Events (QEs), CAPAs and GCP compliance … more
- Novo Nordisk Inc. (West Lebanon, IN)
- …option 14 weeks Paid Parental Leave Free access to Novo Nordisk-marketed pharmaceutical products At Novo Nordisk, you will find opportunities, resources and ... reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- … System and by ensuring accountability for the efficient execution of critical quality tasks. Fostering efficiency, maintaining compliance with cGMP and other ... and offers an exceptional gateway to the fascinating world of fast-paced pharmaceutical manufacturing. The Quality Execution Coordinator will gain unprecedented… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …zero defect manufacturing and maintaining strong and efficient conformance to all quality expectations and compliance with all regulatory standards. This ... and prospective customers. Key metrics: Customer Satisfaction, Audit non-conformances, Regulatory Compliance , Cost of Quality , Validation on Time. Job… more
- Formation Bio (New York, NY)
- …and documentation to ensure the consistent production of safe, effective, and high- quality pharmaceutical products. Cultivate support and commitment across other ... abreast of changes in regulations, guidelines, and industry trends related to pharmaceutical quality assurance and proactively implement necessary updates to 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 ... reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …strict adherence to cGMPs, established manufacturing practices and procedures, and compliance with quality regulations and guidelines. QC Technician levels ... option 14 weeks Paid Parental Leave Free access to Novo Nordisk-marketed pharmaceutical products At Novo Nordisk, you will find opportunities, resources and… more
- Merck & Co. (Rahway, NJ)
- …of molecules, intermediates, and degradation products to identify potential critical quality attributes.-The incumbent must be able to set strategy and enhance ... must hold one of the following:- PhD Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related fields with at least 7 years of … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... Director, GMP QA Process Excellence is accountable to collect information, analyze quality related process, define strategies to lead to the development and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …used for the manufacture of terminally sterilized and aseptically filled pharmaceutical products into vials, syringes and IV bag formats. Job Responsibilities: ... and cost for completing the projectsAssure that assigned projects are in compliance with State, Federal and local codes which encompass environmental protection, FDA… more
- Merck & Co. (Rahway, NJ)
- …cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends ... and accurate information and status updates to project sponsors and management.Champion compliance and safety; promote a culture of diversity, inclusion, and equity.… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …SQE Manager, QA Compliance , is responsible for managing the Supplier Quality Program at Exela ensuring timely completion of associated activities and ensuring ... and timely completion of associated documentation in support of pharmaceutical production in compliance with all CFR,...to plan and accomplish goals specific to the Supplier Quality Program. This position supports the ongoing development and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... global markets are also met.Cross-Functional Team Participation: Responsible for working with Quality Leaders in each operating site to influence and affect the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Engineer (Clean Utilities), you will provide cross-functional support to operations, maintenance, quality and project teams for site GMP utilities. You will be ... site GMP Clean Utilities infrastructure and systems (WFI, Clean Steam, Pharmaceutical /Oil-Free Compressed Air, Process Gases, HVAC, etc.) and applications in aseptic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... network of relationships with Promotional Review professionals from other pharmaceutical companies, and Professional Organizations. Essential Functions Applies broad… more
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