- Novo Nordisk Inc. (Durham, NC)
- …with Regulations, ISO standards, corporate & local SOPs Reviews & approves documentation for Quality approval - batch records & other documentation Supports ... what matters. The Position Ensures Batch Production Records (BPRs) & relevant quality processes are...documentation (in conjunction with LoB). Performs archiving duties and QA presence & process confirmation on shop floor. This… more
- Merck & Co. (Rahway, NJ)
- …cGMP and regulatory filings. Perform independent quality review and approval of batch records , testing data, and related documents required to release or ... Job Description Job Description: The Rahway based Senior Specialist , Global Development Quality Operations -...include but are not limited to the following: Perform quality assurance activities related to API (including… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of ... QA signature authority on the review of individual batch records , supporting test records ... QA presence on the manufacturing floor. Relationships Quality Assurance . Essential Functions Reviews all manufacturing… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Functions Performs walk-through audits of NNUSBPI Manufacturing facilities Releases product based on Quality Assurance record review and approval by Manager, ... QA signature authority on the review of individual batch records , supporting test records ... Quality Assurance Review and assess Corrective and Preventive Actions Reviews… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionQuality Assurance Specialist (Hybrid) The mission of Quality Assurance is to safeguard the rights and well-being of patients; comply with ... investigations, deviation management, and Corrective/Preventative Actions (CAPAs)Previous background in quality control, quality assurance , auditing, or… more
- Merck & Co. (Durham, NC)
- …in pharmaceutical operations, technical operations, validation and/or process Quality Assurance .Required Experience and Skills:Strong Batch Record Review ... high level/ priority projects, ensuring timely completion.Preferred Experience and Skills: Quality Technical experienceElectronic Batch Records (MES)cGMP… more
- Merck & Co. (Durham, NC)
- …harvest, lyophilization, product inspection, and quality control laboratories.The Senior Quality Assurance Specialist will support this expansion. ... Job DescriptionPosition Description: Senior Specialist , Quality Assurance Our...formulation vessel, lyophilizers, etc.). Review and approval of master batch records , executed records , technical… more
- Merck & Co. (Durham, NC)
- …harvest, lyophilization, product inspection, and quality control laboratories. - The Quality Assurance Specialist will support this expansion. Project ... Job DescriptionPosition Description: Specialist , Quality Assurance 1st...of environmental monitoring data. Perform review of process simulation batch records . Perform Quality retain… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing complianceKnowledge of cGMP regulations and ... preferred.Experience authoring and executing documentation including but not limited to: Batch Records , SOPs, Work Instructions, CQV protocols.Experience with… more
- Catalent Pharma Solutions (Harmans, MD)
- …viral vector-based therapies and vaccines. The Lead Specialist , QA - Batch Disposition is responsible for providing Quality Assurance support for GMP ... **Lead Specialist , QA Batch Disposition**...corporate quality and process improvement initiatives. Represent QA on project teams and represent the Batch… more
- Catalent Pharma Solutions (Harmans, MD)
- …vaccines, and oncolytic immunotherapies. The Senior Specialist , QA - Batch Disposition is responsible for providing Quality Assurance support for ... **Senior Specialist , QA - Batch ...documentation practices (GDP), including but not limited to: executed batch records , master batch … more
- Kelly Services (Lodi, CA)
- …Pay Rate: Night: $29.37/Hour (non-negotiable) Overview: The Quality Assurance Specialist is responsible for reviewing records to comply with QSR and ISO ... please apply. Kelly(R) Science & Clinical is seeking a Quality Assurance Specialist I for...signing in relevant sections of documents. * Reviewing the batch records online, if necessary. * Review… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are currently looking to fill a Quality Assurance Specialist position. This position performs activities supporting dispositioning product and/or raw ... materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs,...alignment with QA policies + Reviewing completed records and batch sheets and working with… more
- Novo Nordisk (Durham, NC)
- …Regulations, ISO standards, corporate & local SOPs + Reviews & approves documentation for Quality approval - batch records & other documentation + Supports ... what matters. The Position Ensures Batch Production Records (BPRs) & relevant quality processes are...documentation (in conjunction with LoB). Performs archiving duties and QA presence & process confirmation on shop floor. This… more
- Kedrion Biopharma (Melville, NY)
- …patients and clinicians in hematology, immunology, neurology, and transfusion medicine. Manufacturing Quality Assurance Specialist (MQA) on the Operations ... their compliance with the established procedures, batch records and cGMP requirements. The specialist is...Quality or Operations department. + Experience with biologics Quality Assurance or Operations plus. + Plasma… more
- Catalent Pharma Solutions (Greenville, NC)
- …clients and/or commercial processes and projects as assigned. The Quality Assurance Specialist will perform batch record review and on the floor ... ** Quality Assurance Specialist , Commercial Manufacturing**...QA role required. + Must have experience with batch record review and on the floor … more
- Kelly Services (Tampa, FL)
- …Quality Assurance Specialist ** **Location: Tampa, FL** **Responsibilities:** + The Quality Assurance ( QA ) Operations Specialist will be a key ... the GMP Manufacturing facility . + QA Specialist will be responsible for product batch ..., SOPs and reports. + Create, revise, and implement quality assurance standard operation procedures and work… more
- Belcan (Berkeley, CA)
- Quality Assurance Document Specialist Job Number: 354878 Category: Regulatory Description: Job Title: Quality Assurance Document Specialist ... Contract Keywords: #qualitycontroldocumentjobs #analyst JOB RESPONSIBILITIES: * Reviewing electronic batch records , interacting with QA ...health authorities audit and how the Quality Assurance review impacts the release of a batch… more
- Astrix Technology (Brownsburg, IN)
- ** Quality Assurance Specialist ** Quality...related to manufacturing activities + Scan batch record documentation such as batch records , ... succeed and grow in the life sciences industry!_ _Our Quality Assurance Specialist position is...Tasks** : What you will do: + Review production batch records , logbooks, and associated documentation to… more
- Boehringer Ingelheim (Fremont, CA)
- …compliance and adherence to regulated QA activities for cGMP operations. **Sr Specialist , Quality Assurance ** + Requires a Bachelor's or higher degree ... and packaging, batch record review, batch disposition, new product introduction/product transfer, external quality...of the department head. + Ability to work independently. ** Specialist , Quality Assurance ** + Requires… more
