- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Procedures. Gown properly following the standard operational proceduresRecord, maintain and review completed production documentation ( batch records , log ... compounding responsibilities (mixer batch , tank batch , & partner batch )Document batch records with the utmost attention to detail using cGMP… more
- Merck & Co. (Durham, NC)
- …external regulatory inspections, presenting on topics as needed. Executes and manages Operations batch record review within established timelines for release ... operation Technical writing experience, ie investigations, change requests, standard operating procedures, batch records , protocols. Must be able to work both… more
- Merck & Co. (Rahway, NJ)
- …and automated equipment, conduct functional testing, assist in clinical batch manufacture as equipment SME, assist with FAT, SAT, installation/qualification ... team with authoring relevant SOPs and specifications to enable clinical batch manufacture.Hands on troubleshooting in a manufacturing environment with an ability… more
- Merck & Co. (Durham, NC)
- …documents to meet schedule milestones. Provide QA shop floor support on batch review , alarm response, incursion response and deviation management. Provide ... Provide QA shop floor support in the execution and review of GMP documentation such as IQ, OQ and...in Aseptic processing, aseptic observations, and techniques. Electronic manufacturing batch records (eMBR) experience. VETJOBS #EBRG Current… more
- Merck & Co. (Rahway, NJ)
- …identify process improvements and ensure adherence to regulatory requirements.Author, review and approve SOPs related to operational changes.Author and/or ... events and clinical complaints, as needed.Work to prepare a room or batch for packaging activities, including the creation of appropriate Packaging documentation as… more
- Merck & Co. (Rahway, NJ)
- …staff.Responsibilities:Ensure processes are run within the capability constraints of the facility.Execute batch processes as needed from either a hands-on role or a ... with respect to repair, cleaning (including documentation and execution), batch execution, building housekeeping, and consumable inventory.Write, issue, and … more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and GMP for all NNUSBPI products. This position has QA signature authority on the review of individual batch records , supporting test records and ... the organizational chart. Essential Functions Reviews all manufacturing and support records to certify compliance with specifications and procedures Works closely… more
- Aequor (West Greenwich, RI)
- … review and approval of cGMP processes, procedures, documents and records . Review logbooks, batch records , attachments, work orders, and other GMP ... from established procedures are documented per procedures. Ensure that production records and testing results are complete, accurate, and documented according to… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …department leaders. Review and participate in manufacturing documentation such as Protocols, Batch Records and Risk Assessments. Review and participate in ... quality event records , such as Change Controls, Deviations, and CAPAs.Develop and implement strategies to improve aseptic manufacturing processes.Collect required samples needed for testing as required.Follow all required work safe practices.Hold peers… more
- Aequor (Framingham, MA)
- …manufacturing and support operations to ensure a culture of continuous compliance. Perform batch record review . Perform quality inspections of intermediates ... and finished goods. Perform review of QC data. Perform logbook review . Provide on the floor (OTF) support to the operations department, including OTF support for… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …on the manufacturing process and QMS systems Revise and create documentation (SOP, batch records , FT's) associated with the manufacture of product, requiring ... of process and equipment improvement initiatives, reviews completed quality records , generates quality deviation responses, drive investigations and has ability… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …corrective and preventive actions including:Provide management oversight for quality control, batch records , and material review board.Provide management ... and oversee the conformance to the QMS through internal audits and management review . In addition, the Quality Director will represent the company as the Quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …preferred.Experience authoring and executing documentation including but not limited to: Batch Records , SOPs, Work Instructions, CQV protocols.Experience with ... integrityExecutes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentationParticipates in authoring… more
- Catalent Pharma Solutions (Harmans, MD)
- …passion are essential to our mission: to help people live better, healthier lives. The ** Batch Record Reviewer I** is responsible for providing support to ... documentation practices (GDP), including but not limited to: executed batch records , master batch ...labels, SMPs, and product specific documents. + Independently executes batch record review for completeness,… more
- Actalent (Mundelein, IL)
- …to clients. MUST HAVE + Bachelor's degree in Chemistry, Biology, or related. + Experience in batch record review , chemistry, data review , HPLC, UPLC, and ... Position: Quality Data Reviewer Responsibilities + Routinely communicate with various individuals...Routinely communicate with various individuals or groups on data review , corrections, issues, and solutions. + documentation of experiments… more
- Kelly Services (Lodi, CA)
- … records and documents, for completeness and compliance with QSR and ISO requirements. * Review batch record to support release of raw materials, work in ... Overview: The Quality Assurance Specialist is responsible for reviewing records to comply with QSR and ISO requirements. They...signing in relevant sections of documents. * Reviewing the batch records online, if necessary. * … more
- ThermoFisher Scientific (Cincinnati, OH)
- …needs, driving the team's daily work plan to ensure results are met. Lead the batch record disposition team to achieve site goals for delivery and accuracy ... ensuring compliance with all relevant directives and procedures. Compile and review batch release documentation packages to ensure they meet our stringent… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are currently looking to fill a Supervisor Quality Assurance ( Batch Record Review ) position. This position performs activities supporting dispositioning ... associated with disposition of raw materials and product (eg receipt, inspection, document review , shipping, etc.), activities may be on the floor or at a desk… more
- Actalent (Philadelphia, PA)
- …of laboratory and manufacturing environments within the biotechnology industry. Responsibilities + Perform batch record review and release in support of US ... + Support the management of document control processes, including reviewing and approving batch records , deviation reports, and change controls. + Ensure all… more
- Traylor Bros., Inc. (Chippewa County, MI)
- Batch Plant Superintendent opportunity with Traylor Bros., Inc.! Traylor Bros., Inc. (TBI) National Heavy Civil division provides comprehensive, cutting-edge heavy ... complex bridge construction and rehabilitation projects across the nation, including world record cable-stayed structures and segmental bridges. The group also has a… more
