- Tris Pharma (Monmouth Junction, NJ)
- …standards and objectivesOversee and manage the maintenance and tracking of Quality Systems including, but not limited to Investigations/OOS/OOT/Lab Event, ... product quality complaintsEngages in activities to continuously assess and improve quality systems by identifying and proactively resolving quality … more
- Merck & Co. (Durham, NC)
- …aspects of the project proceed in compliance with cGMP, regulations, and our Company's Quality Management System . Provide QA shop floor support in the execution ... Job DescriptionPosition Description: Specialist, Quality Assurance 1st Shift - Our Company constructed...including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. - The Quality Assurance… more
- Aequor (Libertyville, IL)
- …and Historians (ie OSIsoft PI). PURPOSE AND SCOPE OF POSITION:The Manufacturing IT Systems Quality & Compliance Specialist - Cell Therapy Manufacturing ... Must have experience with IT Quality & Compliance applications and systems ...pharma/biotech with specific expertise in Supply Chain, Manufacturing, and Quality System disciplines. The candidate needs to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …practices related to HRIS systems , incorporating relevant advancements to optimize system performance and functionality. - Data Quality , Testing and Release ... HR business processes, and business systems requirements. Accountable for global systems implementations inclusive of migrating from one system to another.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team within Global Oncology Medical Affairs (GOMA) is seeking a Publications Systems and Operations Intern to work closely with the Director of Publications ... Operations to optimize department resources for delivery of high- quality medical publications in an efficient and compliant manner. They will assist in the operation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …internal audit process.Support the planning and execution of internal audits for all quality system areas for the manufacturing site; write audit reports, issue ... for the monthly CRB & quarterly QSMR presentations.Fulfills the Quality System audit module site key user... systems used to support audits/inspections.Provide support to quality systems team, ad hoc, for activities… more
- Merck & Co. (Rahway, NJ)
- …findings during documentation reviews. Collect, prepare and analyze data to support quality system metrics and planning. Support compliance activities such as ... GMP. Develop/update SOPs to ensure practices are accurately reflected. Assist in SOP and quality -related system document approval. Support metrics by summarizing… more
- Merck & Co. (Durham, NC)
- …investigations, corrective and preventative actions, reviews and approvals through current Quality Systems (eg, CLUE and SAP).Support and maintain a ... Floor QA proceed in compliance with cGMP, regulations, and our Company's Quality Management System focusing on batch record review, process/aseptic observations,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including complete and accurate detail processed into the correct systems Quality monitoring activities to include CRM system case evaluation, Safety ... and FDA requirements Understands PSP operations, including program business rules, SOPs, systems used (including CRM, Safety system and PSP dashboarding tools),… more
- Merck & Co. (Durham, NC)
- …the project proceed in compliance with cGMP, regulations, and our Company's Quality Management System . Supporting areas such as Design, Commissioning, ... Job DescriptionPosition Description: Senior Specialist, Quality Assurance Our Company will construct a new manufacturing facility to significantly expand its… more
- NetApp (Cranberry Township, PA)
- …lifecycle (design, implementation, testing)Familiarity with Unix based operating system kernels and development environments, eg Linux or FreeBSD.Participate ... in product design, development, verification, troubleshooting, and delivery of a system or major subsystems, including authoring project specifications Write unit… more
- Insmed Incorporated (San Diego, CA)
- …inspections, working with regulators, and vendor/supplier audits.Broad knowledge of risk-based quality systems approaches consistent with ICH Q10 for ... packaging, distribution and releaseFocus on establishing, implementing, and maintaining quality operations systems that support manufacturing activitiesPerform… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …ultimately responsible for the product quality received by the customer and the quality system integrity expected by the customer. The Quality Director ... Position SummaryThe Quality Director is the senior leader and decision maker for the Quality Department and Quality Management System . This position is… more
- Merck & Co. (Durham, NC)
- Job DescriptionSenior Specialist, Quality Systems and ComplianceOur company is expanding its global recombinant vaccine production network by investing and ... the vaccine, comprised of fermentation, microfiltration/ultrafiltration, and chromatography steps.The Quality Senior Specialist provides expertise in the coordination of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Quality Control Testing Scheduler as part of the Quality team based in ... organized QC Testing Scheduler to join our team for Quality Control. The ideal candidate will manage and maintain...ideal candidate will manage and maintain our automated scheduling system , ensuring that all tasks and assignments are executed… more
- NetApp (San Jose, CA)
- …of Linux or other Unix-like Operating System .Experience of CI build systems or automated testingEnsure timely and high- quality code in a fast-paced ... test plan, test cases for new features to be released in product.Automate System / Functional test cases effectively which would save repeated manual testing… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur team is within our Research & Development Division's Quality Assurance, Global Development Quality organization and is responsible for ... and develop strong working relationships with network leaders and progress our systems and process development to the next level. The key responsibilities of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting to the Director of Medical Device and Combination Product Quality Assurance, the Associate Director Quality Engineering & Quality ... to support regulatory filings and audits of data, policies, procedures, and systems to ensure compliance with Medical Device (21CFR 820s) and Combination Product… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …helping to bridge the communication infrastructure between the various subunits of the Quality System and by ensuring accountability for the efficient execution ... Quality Execution CoordinatorPosition Summary:The Quality Execution Coordinator is an integral member of the Quality Department who oversees and manages the… more
- Ochsner Health System (Chalmette, LA)
- …system standardization, competency validation, safety programs, accreditation, and quality /efficiency initiatives. Assists in the orientation and training of ... physician order and procedure to assure accuracy. Utilizes radiology information systems to facilitate care. Explains procedure to patient to ensure understanding.… more
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