- Merck & Co. (Rahway, NJ)
- …with 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 - API, is responsible for independent review and approval… more
- Merck & Co. (Rahway, NJ)
- …development, and seamless technology transfer to commercial sites.The SSO Operations Specialist will provide hands on assistance for daily production activities ... This position is also responsible for ensuring facility readiness for batch processing and shares accountability for the building performance. Ultimately, this… more
- Eisai, Inc (Raleigh, NC)
- …across teams.ResponsibilitiesExecute core processes within Quality area: Review manufacturing batch records for completeness, accuracy, and compliance with ... accordance with internal standards.Support approval and issuance of Master Batch Records (MBRs)Assist with entering events, change...applicable quality assurance functions in a GMP setting (eg, batch record review, SOP writing, auditing, … more
- Aequor (Hicksville, OH)
- …component number. Reviews batch paperwork for accuracy and issues to the batch records clerk. Checks and prepares paperwork for upcoming batches. Sets up ... Packager - Support Specialist 2nd shift Packaging = /hr pay rate...and handling the material/equipment according to product specifications, reviewing batch paperwork, performing line clearances, setting up and monitoring… more
- Aequor (Thousand Oaks, CA)
- …to ensure that GMP standards are maintained in line with current SOPs, batch record documentation, and licenses. Identifying improvement opportunities within the ... work alongside other innovative, driven professionals in this meaningful role. Role: Specialist Manufacturing, New Product Introduction Let's do this! At we strive… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cleaning of equipment, and cryopreservation) according to standard operating procedures and batch records , while recording production data and information in a ... in the treatment of multiple myeloma.Legend Biotech is seeking Operations Support Specialist , Sun-Wed 2nd Shift as part of the Technical Operations team based… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Associate Specialist , is a member of the Site Automation team responsible for the assigned process control systems in support of manufacturing ... Information TechnologyPreferred Experience and Skills:Experience in-PLCs, SCADA, DCSs, MES, Batch Operations (S88/S95), IT, and OEM.Ability to perform aseptic… more
- Actalent (Bridgeton, MO)
- …standards of quality and accountability. Responsibilities + Review and understand batch records , manufacturing protocols, and registration/clinical batch ... Skills + Quality assurance experience with a focus on batch record review and GMP compliance. +...in a QA role, specifically in document review of Batch Records , Equipment Records , Validation… more
- ThermoFisher Scientific (Greenville, NC)
- …to support deviation investigations of moderate to high complexity + Performs quality batch record review + Aids in identification of continuous improvement ... operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for both commercial and product development… more
- ThermoFisher Scientific (Greenville, NC)
- …to support deviation investigations of moderate to high complexity + Perform quality batch record review + Aid in identification of continuous improvement ... operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for both commercial and product development… more
- Amgen (Thousand Oaks, CA)
- …into the manufacturing plant, as well as design electronic batch records supporting these introductions. This " Specialist Manufacturing" role will serve as ... of patients while transforming your career. **NPI / Digital Specialist ** **What you will do** In this critical role...GMP standards are maintained in line with current SOPs, batch record documentation, and licenses. + Identifying… more
- Boehringer Ingelheim (Fremont, CA)
- … Specialist trains junior modelers to learn how to generate batch records , generates and refines batch record creation training materials, and ... develops the trouble shooting skills of the team. The specialist works with client groups (Process Engineers, Operations, Quality)...records in BioMES. Leads team to create new batch record types and systematically evaluate information… more
- Charles River Laboratories (Rockville, MD)
- …applicable internal and external requirements. The QA Specialist II will compile the batch record review records and batch disposition documents ... Perform audits and/ or walkthrough of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and industry… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …and supervising clinical production staff within a specific clinical packaging batch record operation. Responsible for safety, quality, production rates, ... reconciliation, BRNRFT, and timelines adherence in the specific Production Batch Record operation assigned to. This position...room operation. + Responsible for entering data accurately in batch records and logbooks. + Must review… more
- Unither Pharmaceuticals (Rochester, NY)
- …and all associated forms *Entering the information into TabFusion *Scanning completed batch records *Communicating with various customers and sending the ... QA Operations Documentation Specialist Who we are? We are a French..., copy and paste data; add, find and edit records ; select a record , delete a … more
- Catalent Pharma Solutions (Malvern, PA)
- …every patient, consumer, and Catalent employee. **The Role** + Review and approve all batch records prior to production to ensure that they conform to ... **Operations Quality Specialist ** **Position Summary** Catalent, Inc. is a leading...resolve inconsistencies with proper recording and completion of the batch record and associated documentation. + Communications… more
- Merck (Rahway, NJ)
- …and seamless technology transfer to commercial sites. The SSO Operations Specialist will provide hands on assistance for daily production activities while ... This position is also responsible for ensuring facility readiness for batch processing and shares accountability for the building performance. Ultimately, this… more
- Catalent Pharma Solutions (Kansas City, MO)
- …the safety of every patient, consumer, and Catalent employee.** **The Role** + Performs batch record review, product release, and disposition + Draft, review and ... approve technical documents such as procedures or master batch records + Ensures that products are...+ Six Sigma or ASQ certification preferred + Performs batch record review, product release, and disposition… more
- Cambrex High Point (Waltham, MA)
- …involves oversight of document control, training compliance, equipment lifecycle documentation, batch record review, lot disposition, and ongoing support for ... inspections, and management reviews. + Coordinate issuance of lot numbers and Master Batch Records (MBRs) to support GMP manufacturing activities. + Review raw… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- … (MES) will be responsible for development, configuration and testing of Master Batch Records (MBRs) from initial to final design. The successful candidate ... commercial timelines. + Responsible for the development, configuration and testing of Master Batch Records (MBRs) from initial to final design. + Responsible for… more
