- 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,...amount of relevant experience for each level: + Associate QA Specialist - 2+ years + … more
- Regeneron Pharmaceuticals (Troy, NY)
- We are currently looking to fill a Quality Assurance Specialist ( Batch Disposition) position. This position performs activities supporting dispositioning ... product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs,...amount of relevant experience for each level: + Associate QA Specialist - 2+ years + … more
- Integra LifeSciences (Cordova, TN)
- …headway to help improve outcomes. **JOB DESCRIPTION** The Specialist , Quality Assurance ( QA ) is responsible for batch record release, donor record/ ... data entry, auditing, and investigations. The Specialist , QA is responsible for quality assurance...+ Perform quality reviews of donor and batch records + Review and analyze test… more
- Abeona (Cleveland, OH)
- Position Overview The Specialist I, Quality Assurance - Operations performs routine activities associated with manufacturing of cell and gene therapy ... management ensuring procedural and regulatory compliance throughout the manufacturing process. The Specialist , Quality Assurance - Operations will report to… more
- Merck (Durham, NC)
- …harvest, lyophilization, product inspection, and quality control laboratories. The Quality Assurance Specialist will support this expansion. Project ... **Job Description** Our Quality Assurance group ensures all materials...+ Provide QA shop floor support on batch review , alarm response, incursion response and… more
- IFF (Newark, DE)
- …US, 19711 Company: IFF Family of Companies Requisition ID : 492478 Job Description The Quality Assurance Specialist is responsible for the management of ... regulatory requirements and corporate quality standards. The Quality Assurance Specialist works closely...and other quality -related policies to meet product quality standards. + Review Production Batch… more
- Actalent (Wilson, NC)
- Description: The Batch Record Quality Specialist II... review /release in QA . Skills: documentation review , GMP, SOP, Quality Assurance Top ... will be responsible for conducting thorough reviews of manufacturing batch records for completeness and that the required information...record. These individuals will be doing a less technical review as they will be focused on ensuring records… more
- Cambridge Isotope Laboratories, Inc. (Tewksbury, MA)
- Cambridge Isotope Laboratories (CIL) has an outstanding opportunity for a Quality Assurance Specialist I to join the team responsible for the quality of ... Annual Product Review Reports, as needed + Contributor to various QA Quality Program functions when needed (eg Deviation, CAPA, Supplier Management,… more
- Novo Nordisk (Durham, NC)
- …potential? Join Team Novo Nordisk and help us make what matters. The Position Performs quality review & approval of Batch Production Records (BPRs), Change ... presence & process confirmation on shop floor. Relationships Manager, Quality Assurance . Essential Functions + Ensures site...& how to apply required + Understanding of the Batch Review Processes required + Understanding of… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …As a Quality Insurance Specialist II, you will provide Quality Assurance support for Manufacturing process, Critical utilities, provide Quality ... leadership. **How you will contribute:** + Responsible ongoing, daily departmental Quality Assurance support for Manufacturing process or Critical utilities.… more
- Novo Nordisk (Clayton, NC)
- …(Authorized Qualified Person), if role is in batch release. Serve as Quality oversight, review & approval of validation activities associated with projects, ... & process confirmation across FP, utilizing LEAN principles. Relationships Senior Manager, Quality Assurance . Essential Functions + Make decisions on quality… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- We are currently looking to fill a Quality Assurance Specialist position to support the Manufacturing Execution System (MES). This position will support a ... quality assurance initiatives * Perform On-The-Floor quality review of documents * Review...have previous QA operations experience, particularly with batch record review / MES design, implementation… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are currently looking to fill a Quality Assurance Specialist position to support the Manufacturing Execution System (MES). This position will support a ... quality assurance initiatives + Perform On-The-Floor quality review of documents + Review...have previous QA operations experience, particularly with batch record review / MES design, implementation… more
- Novo Nordisk (Clayton, NC)
- …floor & improvement of Quality processes. Relationships Reports to Manager, Quality Assurance . Essential Functions + Ensure that the current Novo Nordisk ... reports & release of API materials, deviations, change controls, review & approval of SOPs, QA presence...checks of validation documentation + Perform activities related to Batch review & release + Review… more
- Novo Nordisk (Clayton, NC)
- …processes & how to apply required + Good Knowledge of the Batch review Processes required + Good Knowledge of quality management systems required + Good ... improvement initiatives within Automation work package. Relationships Manager, Quality Assurance . Essential Functions + Ensure that...checks of validation documentation + Perform activities related to Batch review & release + Review… more
- Novo Nordisk (Clayton, NC)
- …& other documentation. Performs Self Audits (in conjunction with line of business (LoB)); Quality Assurance ( QA ) presence & process confirmation on shop ... regulations. Has product release authority if role is in batch release. Quality oversight, review ...Trends and reports data as applicable. Relationships Senior Manager, Quality Assurance . Essential Functions + Make decisions… more
- Actalent (Irvine, CA)
- …and adverse events; coordinates responses with QA Manager. Skills: Gmp, batch record review , Document control, non conforming, fda Top Skills Details: ... Description: * Performs and/or assists with QA review of production records and...bachelors degree in a life science 3-5 years in quality assurance Experience Level: Intermediate Level About… more
- Novo Nordisk (Durham, NC)
- …pharmaceutical or medical device industry + General knowledge of Batch Review Processes (BRP), validation processes and Quality Management Systems (QMS) ... quality processes are compliant with regulations. Performs quality review & approval of Change Requests...presence & process confirmation on shop floor. Relationships Manager, Quality Assurance . Essential Functions + Ensures site… more
- Novo Nordisk (West Lebanon, NH)
- …and procedures + Releases product based on Quality Assurance record review and approval by QA Manager + Performs regular internal audits of NNUSBPI ... position has QA signature authority on the review of individual batch records, supporting test...international regulatory agency preferred + As applicable, experience with Quality Assurance oversight and support for all… more
- Actalent (Foster City, CA)
- …general instructions on new assignments. Skills: Quality assurance , Gmp, Batch record, Capa, Batch record review Additional Skills & Qualifications: ... Description: Main responsibility is review and release of executed batch ...and/or Good Laboratory Practices (GLPs). Demonstrates working knowledge of quality assurance systems, methods and procedures. Demonstrates… more