- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary The GMP Quality Assurance Internship is a program that provides training for ... real-world experience into the regulated environment. We are currently seeking a GMP Quality Assurance Intern for the year starting in June 2024. This full-time… more
- Catalent (Manassas, VA)
- …Diploma with 3+ years of experience in regulated environment is required. Knowledge of GMP and Quality systems; Ability to read and follow documents (Standard ... POSITION SUMMARYThe Quality Assurance Specialist I is responsible for inspection...from receiving to dispatching. To ensure adherence to company quality standards procedures and policies. Inform the QA management… more
- Merck & Co. (Durham, NC)
- …our Company, Regulatory Agency, and State and Local code requirements for quality , good manufacturing practices ( GMP ), equal employment opportunity, finances, ... - Exercise judgment and decision making to ensure a quality product is reliably produced while managing cost -...and two (2) years of experience in a direct GMP , biotechnology, and manufacturing setting.Required Experience and SkillsAbility to… more
- Aequor (Libertyville, IL)
- …and with Process Engineer(s) to understand different failure modes Works with GMP Quality Systems to deliver completed Root Cause Analysis investigation ... and technical acumen including technical writing skills Preferred experience: Quality management system Complex problem-solving skills, including root cause… more
- Merck & Co. (Durham, NC)
- …our company, Regulatory Agency, and State and Local code requirements for quality , good manufacturing practices ( GMP ), equal employment opportunity, finances, ... make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant… more
- Novo Nordisk Inc. (Durham, NC)
- …customer requirements Ensure processes and roles are established and capable to meet quality specifications & requirements, to include GMP Compliance of the team ... 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
- Aequor (West Greenwich, RI)
- …an associate degree combined with 2 years of General lab experience/lab background, GDP/ GMP experience and or a bachelor's degree also paired with General lab ... experience/lab background, GDP/ GMP experience. Looking for local candidates local to the...the labs for this role. General lab experience/lab background, GDP/ GMP experience, ability to work in teams. 100% onsite… more
- Merck & Co. (Rahway, NJ)
- …Small Scale Organics (SSO) Pilot Plant is a Good Manufacturing Practices ( GMP ) facility within the Process Research and Development (PR&D) organization which enables ... operations, process development activities, compliance investigations/change management, authoring of GMP documentation, and lead other staff in the pilot plant… more
- Merck & Co. (Rahway, NJ)
- …(small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. ... engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This position has QA signature authority ... Performs walk-through audits of NNUSBPI Manufacturing facilities Releases product based on Quality Assurance record review and approval by Manager, Quality … 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 ... documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This position has QA signature authority… more
- Merck & Co. (Rahway, NJ)
- …(small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. ... engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the… more
- Aequor (Athens, GA)
- Shift-first Hours- - 7:30am or 8:00am to 4:00pm or 4:30pm The Associate, Quality Control Data will manage the following functions in the Quality Control ... and regulatory requirements. Responsible as an approved USDA sampler and providing Quality Assurance and Production support as needed. Sample Life Cycle Management:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary The Senior Director, Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA, and oversees multiple levels of ... (Directors, Associate Directors, Managers, contractors as applicable) across the Global PV Quality teams located in Europe and the Americas. This individual is a… more
- Merck & Co. (Durham, NC)
- Job DescriptionOur Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed ... aligned with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our...SME, writing and closing QN and QSAT CAPAs, with GMP experience.Shift: Available for shift work, 4 - 10hr… more
- Merck & Co. (Durham, NC)
- …embraces an inclusive team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required.The Lab Senior ... Responsible for supporting our Manufacturing Division,- Divisional site mission by assuring quality of products and services are of the highest quality ,… more
- Merck & Co. (Rahway, NJ)
- …(small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. ... activities, compliance investigation, change management and the authoring of GMP documentation in any of our enabling facilities.Additional Supported AreasAs… more
- Catalent (Philadelphia, PA)
- Quality Assurance Document Control Supervisor Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Document Control ... global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network.… more
- Merck & Co. (Rahway, NJ)
- …Research Laboratories, our company's Manufacturing Division, Animal Health and GWES. The system is GMP and monitors areas and equipment that are both GMP and ... and the ability to understand, update and implement changes to the GMP system.Ability to problem solve/troubleshoot, with knowledge of root cause analysis.Experience… more
- Aequor (Thousand Oaks, CA)
- …AKTA chromatography, and data analytics and visualization knowledge. Job Summary: The Product Quality Director is the champion for a product team as the Product ... Quality Leader (referred to as PQL), providing technical expertise,...commercial product(s) including timely product data review, ownership of GMP documents and regulatory filing sections, execution of transactions… more
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