- Aequor (South San Francisco, CA)
- …materials for global clinical studies. This includes the coordination of the release of these materials to ensure a timely production of Investigational Medical ... a GMP- and customs-compliant goods receipt dossier for the QA- release of drug products and packaging materials o Request...packaging materials in SAP o Ensure the on time QA- release or AFM ("Authorization for Further Manufacturing") of drug… more
- Novo Nordisk Inc. (Durham, NC)
- …and Support Teams. Additional responsibilities includes ensuring testing of in-process, release , and stability samples are performed in accordance with cGMP, NNPILP ... to ensure data integrity and timely reporting for batch release as needed Facilitate problem solving, investigations, and process...Expert in the area of chemical analysis of in-process, release , and stability testing required We commit to an… more
- Merck & Co. (North Wales, PA)
- …may include user access, improvement ideation, IT requirement backlogs, and release planningIntegrated data model management and administration, which may include ... improvement ideation, IT requirement backlogs, and release planningCollaborating on pipeline reporting and analysis, including but not limited to:Contributing to… more
- Repligen (Waltham, MA)
- …maintaining the day-to-day activities for product manufacture, test and release which include managing analysts' schedules, instrument calibration, validation, PO ... initiativesComplete management of day-to-day analyst schedules and product testing and release requirements for the OPUS product lineDevelop, Monitor and Compile… more
- Merck & Co. (Sacramento, CA)
- …by the contract testing lab(s) to support on time batch release .Additionally, this position will work directly with technical operations, quality, regulatory, ... control.Knowledge with In-Process Controls, drug substance and drug product release , stability, and extended characterization testing for vaccines and… more
- Merck & Co. (Rahway, NJ)
- …product development.Responsible for validating and performing CCIT for clinical supply release and stability testing according to specifications for all programs ... Leads.Support, manage, and coordinate analytical support for vials, medical device release testing in a timely manner following GMP procedures.Document the… more
- Merck & Co. (Rahway, NJ)
- …or Manufacturing O rganizations . - Facilitate manufacturing, packaging , and release of clinical supplies for clinical studies, assist in scale up activities ... technologies, including: continuous manufacturing, t hree d imensional (3D) printing, controlled release , and/or oral delivery of large molecules. - Experience with… more
- AUROBINDO (Durham, NC)
- …key software development lifecycle (SDLC) processes, such as ChangeControl, Release , Deviations, etc.Review and approval of test scripts and defects ... Training Management SystemsWell-versed in SDLC processes including Change Control, Release Management, and Deviation handling for validated systemsCompetent in test… more
- Merck & Co. (Durham, NC)
- …cost.- Responsible for Shift(s) supply performance metrics (Schedule Adherence, Release on Time, Customer service performance, Product Lead Time, etc.).-Continuous ... Improvement - Accountable for developing our Company Production System (MPS) and continuous improvement culture while achieving MPS Targets and business results for the Shift(s).- Develop strategic initiatives related to the manufacturing process, equipment… more
- Novo Nordisk Inc. (Durham, NC)
- …help us make what matters. The Position Perform & review analysis of in-process, release & stability samples in accordance with cGMP, site & corporate policies & ... procedures. Relationships Reports to Supervisor, QC - OFP. Essential Functions Accuracy & Scientific Soundness of Lab Data Environmental Compliance GMP Compliance of Laboratory Maintain testing proficiency for methods Timeliness of Lab Results & Investigations… more
- Merck & Co. (Rahway, NJ)
- …documents.Working knowledge for the design, manufacture, packaging, purchasing, testing, release , storage, and distribution of medical devices and/or medical device ... combination products.Must be able to build relationships within a team environment.Experience using computer systems for Quality Management Systems.Must have working knowledge of regulatory expectations for the design, manufacture/packaging and distribution of… more
- AUROBINDO (Dayton, OH)
- …IPQA, Quality Control, Production, and Supply Chain to meet finished product release goals.Be able to work long hours to support production requirements.Be available ... for overtime, including weekends, as needed for production support. Education & ExperienceHigh School Diploma or Equivalency.Up to 2 years of experience performing in-process checks/verifications in the Manufacturing and Packaging areas of pharmaceuticals… more
- Merck & Co. (Durham, NC)
- …while managing cost - Shift(s) supply performance metrics (Schedule Adherence, Release on Time, Customer service performance, Product Lead Time, etc.)Continuous ... Improvement - Accountable for developing a Company Production System (CPS) and continuous improvement culture while achieving CPS Targets and business results for the Shift(s) - Develop strategic initiatives related to the manufacturing process, equipment, and… more
- Merck & Co. (Rahway, NJ)
- …project activities at external manufacturing sitesFacilitate manufacturing, packaging and release of clinical supplies for clinical studies, assist in scale ... up activities at pilot and commercial scale, and summarize results in technical reports and presentationsEnhance our Company's professional image and competitive advantage through patents, presentations, publications and professional activities and advance… more
- Merck & Co. (Rahway, NJ)
- …project activities at external manufacturing sites - Facilitate manufacturing, packaging and release of clinical supplies for clinical studies, assist in scale up ... activities at pilot and commercial scale, and summarize results in technical reports and presentations - Enhance our company's professional image and competitive advantage through patents, presentations, publications and professional activities and advance… more
- Twist BioScience (South San Francisco, CA)
- …report to the QC manager.What You'll Be Doing Review and release products based on established QC metricsMonitor QC dataInvestigate product/process/quality ... issuesReview of CAPAs, process deviations, root cause analysisPreparation of product and process quality reports by collecting, analyzing, and summarizing information and trendsWrite/review product quality documentationFollow regulatory and ISO 13485… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …expertise and troubleshooting ability to drive effective and robust production, testing and release of product to patients. This person must be able to work 1st ... shift/morning hours.Key Responsibilities Diagnoses, troubleshoot, repair, maintain, all types of HVAC, refrigeration, clean room HVAC, clean steam, cryogenic storage equipment and all types of process equipment and systemsUtilizes knowledge and experience in… more
- Merck & Co. (Rahway, NJ)
- …to design, execute and/or direct the development and qualification of release , characterization, and stability assays for testing of clinical trial material ... and in support of product and process developmentStrong technical problem solving abilityA proven record of external scientific engagement demonstrated by scientific publications and presentations.Ability to work both independently for development of… more
- Aequor (Swiftwater, MN)
- …SOP revisions. - Provide technical support of LIMS to Quality Control, Batch Release , Production, Stability and R&D operations - Provide first level diagnostic of ... incidents and support business users, IS LIMS Administrator and Support Center in the management and timely resolution of technical - Responsible for the master data management process including the updating of specifications and supporting the approval… more
- Genmab (NJ)
- …listings, by writing the corresponding programs and ensuring QC before formal release , for the following non-comprehensive list of deliverables: IB, DSUR, briefing ... packages for FDA, EMA etc., supplementary in-house preparations for DMC-meetings, RP2D- selection preparations, supplementary material for interim analysis and final analyses (eg sub-group or other analyses not pre-defined in the SAP), answers to questions… more
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