- Merck & Co. (South San Francisco, CA)
- …science tools (Spotfire, SIMCA) for data analysis and visualization.Strong understanding with production cell line generation using CHO system and microbial ... assessment strategies.Generate stable cell lines using high-throughput screening.Execute bioreactor production , and FPLC purification of candidate molecules to support… more
- Catalent (Philadelphia, PA)
- …room and equipment set up, equipment verification, routine packaging operations, line clearances, room and equipment cleaning activities. The Quality Inspector will ... will manage those opportunities to implementation and improvement, in partnership with Production personnel. This is a full-time role position: Monday - Friday, 2nd… more
- Merck & Co. (Durham, NC)
- …our Company Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham ... shift operations team (7pm - 7am) on a rotating 2-2-3 schedule.AccountabilityFirst line operations supervisor with a team of individual contributor production … more
- Merck & Co. (Durham, NC)
- …HVAC, CTUs, WFI, CS, etc.), process equipment including Filling Line , Lyophilizer, Autoclaves, Washers, Incubators, etc.Strong technical and customer ... ownersAttends shutdown meetings ensuring activities are tracked and completed PRODUCTION EQUIPMENT SUPPORT Responsible for the preventive maintenance and calibration… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …as our next generation of cutting-edge medications. It's not your average production site - it's a tight-knit, supportive community working together to contribute ... improves business information processes. Acts as the implementation partner for Line of Business (LoB) when implementing new corporate processes or though… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …steam sterilization, sanitation, and documentation activities associated with the production of drug products. This position supports the ongoing development, ... of various commercial and research drug products and formulationsComplete Pre- Line compounding ActivitiesExecute compounding responsibilities (mixer batch, tank batch,… more
- Aequor (Hicksville, OH)
- …requiredJob PurposeTransport assigned operational components, supplies and materials to all production lines. Transport full pallets of finished goods to storage and ... to maintain the efficient flow of product through the production process.Major Accountabilities Apply basic knowledge of SOP's, cGMP's,...required paperwork at end of shift. Fills in for line staff as needed May support the Pharma Operator-… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …as our next generation of cutting-edge medications. It's not your average production site - it's a tight-knit, supportive community working together to contribute ... in alignment with current site strategy to increase API production through efficiency and long term site expansion. It...local standards and systems to successfully execute projects in line with the project execution model, local and BRD… more
- Catalent (Manassas, VA)
- …auditing the products and processes at various points in the areas of production and packaging to ensure adherence to company quality standards. Communicate any ... Food Quality Plan (FQP) standards.Hours: Monday-Friday 10AM-6PM. Provide coverage during production runs on extended shifts and weekends, as needed. Location:… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …judgment to plan and accomplish goals.Job Responsibilities:Complete Pre- and Post- line clearances for each batch recordCheck in labeling/packaging components for ... the current batch recordEmboss cartons using the embossing machineClean production areas in between batchesStock supplies in production areas as neededOpen… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pertaining to external data sets, data structures to ensure delivery is in line with agreed upon EFTs, eDTS, DS External Data Standards and Contract/SOW.Promotes ... with the approved EFTs and eDTS. Participates in review of Test and Production data transfers for diverse data sets and identifies any erroneous data.Lead Companion… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Responsibilities: Clean, set-up, operate and monitor equipment of the production lineComplete all required documentation and scheduled quality checksEnsure adequate ... supply, function, and output of production equipmentAdjust filler to include timing & fill volume...required samples needed for Quality Assurance testing as requiredPerform line changeovers in a safe and efficient mannerComplete pre… more
- Catalent (Manassas, VA)
- …Quality Plan (FQP) standards.Shift: 2nd Monday-Friday 1PM-9PM. Provide coverage during production runs on extended shifts and weekends, as needed. Location: ... System and ensure corrective action is implemented to eliminate them.Work with Production and Packaging Managers, Supervisors, and R&D to maintain and update records… more
- Insmed Incorporated (Bridgewater, NJ)
- …activities related to review of data for interim analysis or blinded data reviews. Production of tables, listings and narratives of safety areas of interest/focus: eg ... related to metabolite, Liver enzymes. Review of mortality cases, evaluation of CIOMS, production of queries to address information gaps in CIOMS of such deaths.… more
- Catalent (San Diego, CA)
- …every patient, consumer, and Catalent employee. The Role:Reviews and dispositions production batch records for product release. Determines if records are compliant ... activities including release of GMP materials, shipment verification and performance of line clearances in a Class 100,000 environment, maintenance of clinical trial… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …perform acceptance quality limit (AQL) inspectionReconcile and review executed batch production records for batch release Ensure outgoing shipments meet guidelines ... batch records during active manufacturing Perform routine manufacturing area line clearancesMaintain gowning qualification for access to aseptic manufacturing areas… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …non-classed area into cleanroomsComplete Pre- and Post-cleanings for each batch recordComplete Pre- line and Post- line for each batch recordRetrieve, prepare, and ... DepyParticipate in weekly cleaning routine of all cleanroomsAssemble daily production tags/labels for traceability of finished productPrepare components for… more
- Catalent (San Diego, CA)
- …the direct report on analytical data review of stability and release data.Perform Line Clearance activities to ensure the correct equipment and materials have been ... staged in the manufacturing suite before the production begins.Perform the release, quarantine and rejection of raw...quarantine and rejection of raw materials used in the production of samples and approve the respective specification of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for identification, preservation, collection, processing, review / analysis, and production of hard copy and electronically stored information Manage relationships ... drive the adoption of sound data management practices and enhance partnership with Line of Business Partner with other key stakeholders in Novo Nordisk's broader… more
- First Solar (Trinity, AL)
- …English* Able to trouble shoot and solve problems on the manufacturing line * Ability to deal with administrative as well as technical tasks*Essential ... Responsibilities:** Solve day-to-day production , equipment, and process problems* Identify and implement yield...performance and associated product performance* Support the operation of pilot- line equipment to define a new process* Transition new… more
