- 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...presence & process confirmation on shop floor. Relationships Manager, Quality Assurance . Essential Functions Ensures site compliance… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe main functions of the Specialist , Quality Assurance is to assist in the review of batch records , media batch release, ... quality operations.Understanding and application of cGLPs and cGMPs.Experience with batch release, and quality systems management;-Knowledge of LIMS Preferred… more
- Aequor (Devers, TX)
- …the QA Operations organization at the LSCC in Devens, MA. The Contractor Field QA Specialist is responsible for quality activities for the LSCC in ... QA on the floor activities. Ensure manufacturing compliance with applicable procedures and batch records . Perform real time review of manufacturing batch … 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
- 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 ...leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all… more
- Merck & Co. (Durham, NC)
- …matters.Review and approval of batch record documentation (electronic batch record comment resolution, autoclave records , review and approval ... Job DescriptionOur Quality Assurance group ensures every single...of electronic and paper batch records as applicable)Provide Quality oversight to alarm… more
- Piper Companies (Lansdale, PA)
- …and growing pharmaceutical manufacturer.Responsibilities for the QA Clinical Supplies Specialist :. Electronic batch record review of finished clinical ... 401k w/ ADP Keywords: clinical supplies, biologics, vaccines, electronic batch record review, batch ...specifications, labeling, regulatory submissions, SAP, Trackwise, Midas, Veeva, QMAS, QA , Quality Assurance #LI-JM1 #LI-ONSITE… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing compliance Knowledge of cGMP regulations ... preferred. Experience authoring and executing documentation including but not limited to: Batch Records , SOPs, Work Instructions, CQV protocols. Experience with… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …execute, and evaluate change requests) Revise and create documentation (SOP, batch records , reports) associated with technical operations, production, ... Work on cross-functional teams with Validation, Engineering, Manufacturing, Project Management, Quality Control, Facilities, and Quality Assurance Performs… more
- Axelon Services Corporation (Bothell, WA)
- …skills include- strong cross-functional experience, strong interpersonal skills *Job Description: The Quality Assurance Specialist position plays a key role ... 3-5 years of GMP work experience - Familiarity with Batch Records - Deviations Experience Preferred -...a regulated cGMP environment. The primary focus of the QA Specialist role will be to support… more
- Axelon Services Corporation (Bothell, WA)
- …Shift is from 9 Pm-7:30 Am Wed-Sat The QA Shop Floor Specialist is responsible for quality activities supporting Manufacturing Operations in accordance with ... have sound knowledge and experience in FDA regulated cGMP Quality Manufacturing operations and processes. * Directs quality...issues. * Ensure manufacturing compliance with applicable procedures and batch records . * Perform real time review… more
- Cynet Systems Inc. (New Brunswick, NJ)
- …be very detail oriented and be able to quickly detect errors within documentation. The Quality Assurance Specialist will provide Quality oversight to the ... documents and ensuring compliance to GMP. Documents to include batch records , logs, and others. Ability to...the ability to be on site up to support Quality Reviews and QA Shop Floor manufacturing… more
- Nesco Resource (Central Islip, NY)
- …Central Islip, NY. QA Validation SpecialistResponsibilities Responsible for providing Quality Assurance support for receiving/releasing GMP documentation of ... records , product labels, and product-specific documents Independently executes batch record review for completeness, accuracy, and cGMP compliance.… 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
- 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
- Actalent (Raleigh, NC)
- Description: The Batch Record Quality Specialist II will be responsible for conducting thorough reviews of manufacturing batch records for ... technical review as they will be focused on ensuring records are meeting quality standards for the...in QA . Skills: documentation review, GMP, SOP, Quality Assurance Top Skills Details: documentation review… more
- Actalent (Newark, CA)
- Description: Quality Assurance Specialist II...audit, document control, quality assurance , quality control, batch record Additional ... assist in quality operations area, such as batch record and quality control... quality operations, as needed (eg, review executed records such as batch records /… more
- Lilly (Durham, NC)
- …and a fully automated visual inspection. The Quality Assurance Floor Support Specialist works as a member of the QA Floor Support team and reports to ... and approves GMP documentation in support of daily operations such as: electronic batch record logs, paper logbooks, cleaning, and procedures versus performance.… more
- Editas Medicine (Cambridge, MA)
- …and equipment as well as process commissioning & qualifications. + Review executed batch records , associated testing records , and other documentation to ... and review. + Author, review and approve GMP documentation (SOPs, batch records , protocols, technical reports, test methods, protocols, specifications,… more
- Abbott (Sturgis, MI)
- …and compliance to all Abbott policies, procedures, requirements, and government regulations + Elevate batch record quality issues to Quality Systems ... serve people in more than 160 countries. **Job Title:** Batch Records Auditor **Working at Abbott** At...ensure each is investigated prior to Production supervision or Quality Assurance specialist review +… more
