- Actalent (Wilson, NC)
- Description: The Batch Record Quality Specialist II will be responsible for conducting thorough reviews of manufacturing batch records for ... information is allocated into the proper sections of the record . These individuals will be doing a less technical...technical review as they will be focused on ensuring records are meeting quality standards for the… 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, and Regeneron Standard Requirement Documents. In… 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, and Regeneron...advice in alignment with QA policies + Reviewing completed records and batch sheets and working with… more
- Integra LifeSciences (Cordova, TN)
- …, Quality Assurance (QA) is responsible for batch record release, donor record / batch record quality reviews, all quality record ... for quality assurance metrics and maintaining all quality records / batch records ...safely to finished goods for final distribution + Perform batch record review and release for all… more
- Danaher Corporation (Duncan, SC)
- …of solutions that safeguard and improve human health. What you'll do: + Review batch documentation records to ensure goods are being released in compliance with ... Bachelor's degree or 1-3 years of experience in a quality and production environment + Good knowledge of ...quality and production environment + Good knowledge of quality standards: GMP Requirements, Good Documentation Practices + Excellent… more
- WellSpan Health (Chambersburg, PA)
- …system, analyzes, unitizes, answers phones, purges for microfilm, and scans patient records ( batch prep, acquisition, indexing, quality assurance, etc.). ... Medical Records Specialist Location: Chambersburg Hospital, Chambersburg,...the Meditech system and attaching miscellaneous reports to the record . 13. Batch preps records … more
- Mallinckrodt Pharmaceuticals (Hobart, NY)
- …tracking in the Batch Record Activity Tracker (BRAT), of all batch records through the Manufacturing and Packaging process (as applicable). + Prioritizes ... review of medium to high complexity for all manufacturing batch records at appropriate stages in order...including coaching and mentoring operators and technicians on proper batch record documentation. + Assists in training… more
- Abeona (Cleveland, OH)
- … systems in support of a cGMP Operation for production processes relating to batch record review and release from start to end of manufacturing activities, ... Position Overview The Specialist I, Quality Assurance - Operations...Documents include but are not limited to: Master Production Records , Quality Control test methods/forms, Method Qualification/Validation… more
- Endo International (Rochester, MI)
- …and identify complex errors such as calculation conversions + Able to reconcile batch record entries with other documentation + Proof-reading skills and ability ... Summary - a concise overview of the job The Quality Associate Specialist , Product Release, under close..., Product Release, under close supervision, reviews all pertinent records , including Batch Production Records … more
- United Therapeutics (Eden Prairie, MN)
- …is critical to ensuring finished product is manufactured to approved manufacturing batch records and processes. + Manufacturing Floor Support: Provide routine, ... ensuring adherence to GMPs (GDPs) and established internal documentation including SOPs, Master Batch Records (MBRs), and Test Methods (TMs). Reports errors in a… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …* Reviewing company documentation including SOPs, SPECS, Process Transmittals, and Manufacturing Batch Records to assess MES impact * Identifying difficulties ... We are currently looking to fill a Quality Assurance Specialist position to support...* Reviewing and approving MES recipes, design specifications, master batch records , and electronic records … more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …+ Reviewing company documentation including SOPs, SPECS, Process Transmittals, and Manufacturing Batch Records to assess MES impact + Identifying difficulties ... We are currently looking to fill a Quality Assurance Specialist position to support...+ Reviewing and approving MES recipes, design specifications, master batch records , and electronic records … more
- Actalent (Stratford, CT)
- …Diagnose and propose areas of growth within current QMS Print, scan, file, and archive batch records and other quality documents Support the Director of ... Experience working in a cGMP environment Experience working with and familiarity with cGMP quality documentation such as batch records , NCRs, CAPAs, SOPs,… more
- Actalent (Foster City, CA)
- …receives very little instruction on routine work, general instructions on new assignments. Skills: Quality assurance, Gmp, Batch record , Capa, Batch ... Description: Main responsibility is review and release of executed batch records coming out of contract mfg / packaging vendors. Primarily packaging. These… more
- Actalent (Stratford, CT)
- …Diagnose and propose areas of growth within current QMS + Print, scan, file, and archive batch records and other quality documents + Support the Director of ... cGMP OTC, medical device, and pharmaceutical products + Post-production batch record review and approval + Review...environment + Experience working with and familiarity with cGMP quality documentation such as batch records… more
- Unither Pharmaceuticals (Rochester, NY)
- Quality Specialist - Development & Validation Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products ... and Capsules. It has more than 280 employees. Your role Reporting to the Quality Assurance Manager, The Quality Specialist (Development and Validation)… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …interviews, flowcharting, and other informational gathering. + Review electronic batch records , identify nonconformance's and participate in investigation ... my knowledge. **Job Description** **About the role:** As a Quality Insurance Specialist II, you will provide...(TrackWise), Process control systems (Delta V, BAS, PLC), Electronic Batch Record Management. + Must have knowledge… more
- Kedrion Biopharma, Inc. (Melville, NY)
- …deviations and product/system failures. + Reviewing, editing, and revising controlled documents ( batch records , logbooks, SOPs, etc.) in accordance with cGMP ... + Problem solving skills, results oriented. + Experience with pharmaceutical investigations and batch record review. + Knowledge of Microsoft Office and e-mail… more
- Lilly (Durham, NC)
- …and approves GMP documentation in support of daily operations such as: electronic batch record logs, paper logbooks, cleaning, and procedures versus performance. ... isolator technology and a fully automated visual inspection. The Quality Assurance Floor Support Specialist works as...(Excel, Word, PowerPoint, Outlook), inventory control (SAP), and electronic batch records (PMX) + Ability to work… more
- Actalent (Irvine, CA)
- …observed deficiencies, and contributes to establishing solutions to observations. * Issues batch records , checks yield and reconciliation calculations, and fiels ... on complaints and adverse events; coordinates responses with QA Manager. Skills: Gmp, batch record review, Document control, non conforming, fda Top Skills… more