- Merck & Co. (Durham, NC)
- …lyophilization, product inspection, and quality control laboratories. The Quality Assurance Specialist will support this expansion. Project activities ... Job DescriptionOur Quality Assurance group ensures all materials inside our...floor support in the execution and review of GMP documentation such as IQ, OQ and other technical documents… more
- Merck & Co. (Durham, NC)
- …demand for the future. Our Quality Engineering (QE) group, a part of Quality Assurance (QA), is seeking a Senior Specialist that will support the ... controls, SOPs, Work Instructions, Job Aids, Preventive Maintenance (PM) and Calibration documentation , Quality Risk Assessments (QRAs), and other cGMP related … more
- Novo Nordisk Inc. (Durham, NC)
- …compliance with Regulations, ISO standards, corporate & local SOPs Reviews & approves documentation for Quality approval - batch records & other documentation ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...review & approval of Change Requests (CR's) & other documentation (in conjunction with LoB). Performs archiving duties and… more
- Novo Nordisk Inc. (Durham, NC)
- …with Regulations, ISO standards, corporate & local SOPs Reviews & approves documentation for Quality approval - components/raw material, batch records, change ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...Production Records (BPRs), Change Requests (CR's), Deviations & other documentation (in conjunction with LoB) & QA presence &… more
- Novo Nordisk Inc. (Durham, NC)
- …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 ... with IT, metrology & other key stakeholders to ensure the right quality , cost & timely completion of all deliverables. Relationships Manager. Essential Functions… more
- Merck & Co. (Rahway, NJ)
- …GMP clinical manufacturing plant in Rahway, New Jersey.- The role at the Specialist level will be responsible for analyzing monthly forecasts and assessing current ... identify excipients and components that need to be purchased.- The forecasting specialist will ensure that purchased excipients and components are received and… more
- Merck & Co. (Rahway, NJ)
- …a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position will report to the Director, Engineering, ... utility systems and associated infrastructure.- Responsibilities of the Senior Specialist - Manufacturing Automation include the following:The automation engineer… more
- Aequor (Seattle, WA)
- …System (LMS). The position will report to the Global Cell Therapy Quality Training Lead REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: Must have basic ... GMP and Quality knowledge. Intermediate skills to navigate a document management...procedure. Review training form submissions for adherence to good documentation principals, accuracy and completion. Oversee the creation, edit… more
- Merck & Co. (Durham, NC)
- … quality , IT, and engineering groups. - The Senior Specialist for Manufacturing Automation is responsible for providing automation technical support ... documentation . Initiate and lead collaboration within the Operations, Quality and Technical organizations to resolve complex problems. Responsible for… more
- Catalent (Manassas, VA)
- … Specialist - 2nd Shift is responsible for creating and maintaining the Quality System documentation . Communicate any deviations to management. Assist the ... based positionThe Role:Support the creation and maintenance of all documentation related to the Quality System utilizing...maintenance of all documentation related to the Quality System utilizing technical writing skills to ensure proper… more
- Catalent (Manassas, VA)
- …with complex formulations to help create engaging new products consumers will love.The Quality Assurance Specialist I - Quarantine is responsible for auditing ... in the areas of production and packaging to ensure adherence to company quality standards. Communicate any deviations to management. Assist the Quality Assurance… more
- BioAgilytix (Durham, NC)
- …role and you will be a critical part of our beginning-to-end client data quality processes. Through your technical reviews of raw and processed data, you will ensure ... settings, and workflows. You are the bridge between the lab and the quality assurance team, combining observations on regulatory requirements with your knowledge of… 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 ... is responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and… more
- Novo Nordisk Inc. (Durham, NC)
- …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 ... party instrument services Accurately & legibly records all activities in appropriate documentation . Writes work orders Reviews documentation for accuracy &… more
- Aequor (Devers, TX)
- …at the Single Use Facility (SUF) in Devens, MA. The Contractor Field QA Specialist is responsible for quality activities for the Single Use Facility in ... 10:30 PM hour shift M>Fri as detailed in JD. Candidate must have Quality Assurance experience with strong independent judgment. Job Description: Field QA … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking QC Specialist , Lab Services - I, II, III as part of the Quality team ... based in Raritan, NJ. Role Overview The QC Specialist , Lab Services, is responsible for sample management. The...on routine tasks and have conceptual understanding of all Quality Control functions and business areas. May need supervision/support… more
- Merck & Co. (Rahway, NJ)
- …in supporting the process automation systems within clinical manufacturing.-The Automation Specialist - Engineering Auto Eng position will report to the Director, ... and develop appropriate system validation, change control, and testing documentation .Maintain familiarity with system life cycle documentation methodology… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- The QA Specialist II - Engineering/Validation is responsible for cGMP compliance ensuring all FDA regulations, internal procedures/specifications, and other ... to as it relates to review and approval of engineering/validation specific documentation . He/she must ensure all equipment installed, qualified or validated at the… more
- Aequor (Seattle, WA)
- …Maintain and control electronic document content and folders as per good documentation requirements in compliance with Quality Systems and retention programs ... Job Description: JOB TITLE: Training Specialist Location: Seattle, WA - 1000 Dexter (100%...and implementing correctives Innovative, proactive, and resourceful; committed to quality and continuous improvement Strong computer skills with MS… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …The Position This position will reviews manufacturing and support documentation and records to certify compliance with in-house specifications/standards and ... assess Corrective and Preventive Actions Reviews and approves validation documentation Reviews and assesses deviations; includes tracking, follow-up and… more
