- Merck & Co. (Durham, NC)
- …during processing, review and approval of incursions, review and approval of batch record documentation, and Reports.Requires working high level of knowledge and ... to include the following:Direct in-line Quality support for all cGMP compliance, batch review, and environmental monitoring matters.Review and approval of batch … more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …drug products and formulationsComplete Pre-Line compounding ActivitiesExecute compounding responsibilities (mixer batch , tank batch , & partner batch )Document ... standard operational proceduresRecord, maintain and review completed production documentation ( batch records, log books, etc.) for quality and cGMP complianceWork… more
- Merck & Co. (Rahway, NJ)
- …This position is also responsible for ensuring facility readiness for batch processing and shares accountability for the building performance. Ultimately, this ... in equipment setups, raw material sampling and subdivisions, solution preparations, batch processing planning and execution at a pilot scale, process knowledge… more
- Catalent (St. Petersburg, FL)
- …for Quality aspects related to Quality Systems, Finished Product Batch Release, Change Control, Client interface, Lab Investigations, Deviations, Complaints, ... and associated Master documents, including but not limited to Master Batch Records; Master Shipper Labels, Process recipes, various technical protocols… 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 in ... and customer audits. 1. Performs general and/or more complex manufacturing formulation batch production record reviews and approval in support of product release in… more
- Merck & Co. (Rahway, NJ)
- …Environment (S&E) and GMP requirements as well as ensuring facility readiness for batch processing. In addition, this position is expected to work cooperatively with ... include but are not limited to: Lead, prepare for and/or support batch processing readiness and execution activities. Prepare, review, and/or approve GMP… more
- Catalent (St. Petersburg, FL)
- …responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control.The QA Product Manager provides customer service, ... to MERs and material Specifications; Product specifications; Test methods; Master Batch Records; Master Shipper Labels; all equipment IQ/OQ/PQ documents regarding… 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 review… 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 QA shop ... approval.Experience in Aseptic processing, aseptic observations, and techniques.Electronic manufacturing batch records (eMBR) experience.NOTICE FOR INTERNAL APPLICANTSIn accordance with… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to ensure completion of assigned workReview documents such as Protocols, Batch Records, Change Controls, Deviations, CAPAs, Risk Assessments, etc Evaluate the ... corrections/modification are done effectively and in a timely mannerEnsure that all Batch Production Records are correctly filled out and completed in a timely… 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 to cGMP ... investigations, create/revise operational procedures, including manufacturing work instructions, master batch records, forms, and support and manage change controls.… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …identify root cause, evaluate technical impact, and provide recommendations on batch disposition Facilitates and collaborates with cross functional groups like ... Manufacturing Investigation records Provide follow-up and scheduling to ensure the batch release process is not impacted by outstanding deviations Ensure… 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 ... to address challenges related to deviation management, investigation quality, and batch disposition timeliness. Foster a culture of accountability and continuous… more
- Catalent (St. Petersburg, FL)
- …events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation ... recurrence; ensure on time closure. May author other types of quality system documents as directed or assigned by QA management. Liaise with customers to ensure customer requirements are satisfied. Facilitate CAPA commitments and Effectiveness Checks,… more
- Catalent (St. Petersburg, FL)
- …including but not limited to Quality Systems, Finished Product Batch Release, Training, Internal/External Audits, Complaints, APR, Investigations, Document Control, ... Equipment/Facilities, Change Control, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure of the Quality Unit and could include all or some aspects of the Quality function.The RoleEnforce Computerized System… more
- Catalent (Manassas, VA)
- …soft chews for nutritional supplements and nutraceuticals, as well as small batch lozenges. With extensive development and manufacturing expertise and a wide range ... of flavors, ingredients, and colors available, we can work with complex formulations to help create engaging new products consumers will love..The Role: Conduct thorough and detailed quality inspection and check of lines to ensure products meet established… more
- Novo Nordisk Inc. (Durham, NC)
- …lab generated data to ensure data integrity and timely reporting for batch release as needed Facilitate problem solving, investigations, and process improvements ... Responsible for ensuring laboratory areas are inspection ready Responsible for supervising their team to include performance management, coaching, development, engagement, and annual merit review Ensure that reporting personnel have individual development… more
- Catalent (Manassas, VA)
- …soft chews for nutritional supplements and nutraceuticals, as well as small batch lozenges. With extensive development and manufacturing expertise and a wide range ... of flavors, ingredients, and colors available, we can work with complex formulations to help create engaging new products consumers will love.Location: Manassas, VAShift: 6AM-6PM continental shift (2-2-3) with rotating weekendsThe Role: Perform stablished… more
- Catalent (Philadelphia, PA)
- …responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, Change Control, and Customer relations.The Role: Provides direction ... and guidance to the Quality Disposition, Materials Sampling Quality Assurance, Regulatory and Compliance Quality Assurance, and Validation Quality Assurance. Management responsibilities include professional development, performance appraisals, and employee… more
- Catalent (Manassas, VA)
- …soft chews for nutritional supplements and nutraceuticals, as well as small batch lozenges. With extensive development and manufacturing expertise and a wide range ... of flavors, ingredients, and colors available, we can work with complex formulations to help create engaging new products consumers will love.The Role: Act as change agent in organization driving production to meet customer demand; Daily monitor for accurate… more
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