- Catalent (Philadelphia, PA)
- …Assurance Document Control individual is responsible in preparing customer files, review and approve batch records , and release batch records and ... primary liaison to our customer's quality assurance groups for batch record review and release. The Quality...and Catalent employee. The Role Review and approve all batch records prior to production to ensure… more
- Catalent (Philadelphia, PA)
- …and activities associated with batch record documentation, reviewing and approving batch records , and releasing batch records and finished ... every patient, consumer, and Catalent employee. The Role: Responsible for ensuring batch record documentation aligns with activities performed and is compliant… more
- Catalent (San Diego, CA)
- …individual will be responsible for evaluating the compliance of documents such as batch records , equipment records , environmental monitoring records , ... of every patient, consumer, and Catalent employee. The Role:Reviews and dispositions production batch records for product release. Determines if records are… more
- Catalent (San Diego, CA)
- …of every patient, consumer, and Catalent employee. The Role:Reviews and dispositions production batch records for product release. Determines if records are ... compliant with internal and cGMP regulations;Liaison between Manufacturing and QA for executed Batch Record Review and flow of documents;Liaison between QA and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …ActivitiesExecute compounding responsibilities (mixer batch , tank batch , & partner batch )Document batch records with the utmost attention to detail ... following the standard operational proceduresRecord, maintain and review completed production documentation ( batch records , log books, etc.) for quality and cGMP… more
- Catalent (Philadelphia, PA)
- …and GMP standards are being followed during the packaging process. Reviews the batch record and any associated paperwork for any documentation errors made ... operation and again when the job is completed prior to submitting the batch record for final review and release. Prints and reviews Material Usage Reports for… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …judgment to plan and accomplish goals. Job Responsibilities:Prepare vials and verify with the batch record . Ensure part number, quantity and expiries match the ... batch record . Transfer vials from non-classed area into cleanroomsComplete Pre- and Post-cleanings for each batch recordComplete Pre-line and Post-line for… more
- Aequor (Bothell, WA)
- …in-process materials and finished product; investigates and resolves GDP errors; Performs batch record reviews. Assures the quality of manufactured products are ... Drafts and reviews specifications and SOPs. Monitors and trends batch record errors and provides Quality Assurance management with quality indicator… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …information is accurate and provide approval after packaging activitiesReview batch records during active manufacturing Perform routine manufacturing ... and perform acceptance quality limit (AQL) inspectionReconcile and review executed batch production records for batch release Ensure outgoing shipments meet… more
- Catalent (St. Petersburg, FL)
- …controls and associated Master documents, including but not limited to Master Batch Records ; Master Shipper Labels, Process recipes, various technical protocols ... Protocols and Reports (non-GMP, Clinical, Registration, Process Validation, Product Transfer)Master Batch Records ; and Master Shipper Labels.Change Control, as… more
- Novo Nordisk Inc. (Durham, NC)
- …SOPs Reviews & approves documentation for Quality approval - components/raw material, batch records , change control requests, deviations & validation documents ... what matters. The Position Performs quality review & approval of Batch Production Records (BPRs), Change Requests (CR's), Deviations & other documentation (in… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …NNUSBPI products. This position has QA signature authority on the review of individual batch records , supporting test records and other ancillary support ... responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …during investigations. Ensure prevention of recurrence and improvement of batch disposition timeliness. Performance Monitoring, Reporting and Management: Monitor ... KPIs related to investigation quality, timeliness, closure rates, overdue records , and deviations recurrence, and take proactive measures to address gaps and improve… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Mock cell, and CAR-T process) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according ... investigations, create/revise operational procedures, including manufacturing work instructions, master batch records , forms, and support and manage change… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …NNUSBPI products. This position has QA signature authority on the review of individual batch records , supporting test records and other ancillary support ... responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Investigation records Provide follow-up and scheduling to ensure the batch release process is not impacted by outstanding deviations Ensure investigations will ... identify root cause, evaluate technical impact, and provide recommendations on batch disposition Facilitates and collaborates with cross functional groups like… more
- Catalent (St. Petersburg, FL)
- …limited to MERs and material Specifications; Product specifications; Test methods; Master Batch Records ; Master Shipper Labels; all equipment IQ/OQ/PQ documents ... responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control.The QA Product Manager provides customer service,… more
- Aequor (Thousand Oaks, CA)
- …and use of quality systems. Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and ... quality approval of minor deviations and CAPA records . Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …techniques. Perform process unit operations according to standard operating procedures and batch records , and record production data and information ... in a clear, concise, format according to Good Documentation Practices (GDP). Perform tasks on time in a manner consistent with quality systems and cGMP requirements. Work in a team based, cross-functional environment to complete production tasks required by… more
- Catalent (Manassas, VA)
- …materials necessary to meet production goals and requirements. Verifies and keeps records on incoming and outgoing product & material movements, accurately. Process ... soft chews for nutritional supplements and nutraceuticals, as well as small batch lozenges. With extensive development and manufacturing expertise and a wide range… more
