Process Validation Engineer - Durham, NC
https://www.indeed.com/viewjob?t=process+validation+engineer&jk=f1468732f1044374&_ga=2.70128336.1774600758.1551098615-2077807285.1533320279
Wednesday, February 27, 2019
Process Validation Engineer - Durham, NC
Process Validation Engineer - Durham, NC
https://www.indeed.com/viewjob?t=process+validation+engineer&jk=f1468732f1044374&_ga=2.70128336.1774600758.1551098615-2077807285.1533320279
Tuesday, February 26, 2019
Computer System Validation - Berkeley, CA - KatalystHLS.com
Review and coordinate the draft protocols/test cases, Review validation deliverables, Support periodic reviews, Manage and monitor Audit and CAPA management, Professional experience in managing quality / compliance in the regulated environments in a Pharmaceutical/Life Sciences Organization.
https://www.indeed.com/viewjob?t=computer+system+validation&jk=bd45212442c04c18&_ga=2.10069239.392766278.1551093961-1763958782.1550934870
Monday, February 25, 2019
Research Associate Scientific II - Chicago, IL.
Make sound technical recommendations regarding projects/matters that are more routine than not. Provide some analysis/redesign of key experimental procedures. Employ appropriate techniques/methods to successfully and independently execute routine assignments within negotiated deadlines. Endure compliance in all research, data collection and reporting activities performed. Recommend appropriate improvement for assigned tasks where needed. Knowledge and understanding of GxP and related regulations and guidance, is preferred. || www.KatalystHLS.com || #KatalystHLS
https://www.indeed.com/viewjob?t=research+associate+scientific+ii&jk=82e8cbb6435a8ea8&_ga=2.99263068.392766278.1551093961-1763958782.1550934870
Sunday, February 24, 2019
Merck to Acquire Immune Design
Merck to Acquire Immune Design: Merck & Co. Inc. (NYSE:MRK) will acquire cancer vaccine company Immune Design Corp. (NASDAQ:IMDZ) to boost its cancer immunotherapy pipeline. Merck will pay $5.85 per share in cash, or about $300 million. The price is a 312% premium to Immune Design\'s closing price of $1.42 Wednesday, before the deal was announced. Immune Design gained $4.40 (310%) to $5.82 on Thursday. Immune Design has two vaccine immunotherapy platforms. Its ZVex lentiviral vectors stimulate dendritic cells to initiate production of antigen-specific cytotoxic immune cells, and its GLAAS platform boosts helper immune cells.
https://www.businesswire.com/news/home/20190221005198/en/
Saturday, February 23, 2019
Computer System Validation - Berkeley, CA.
Play the role of coordinator for Change / CAPA / ER. Prepare and facilitate IT Change Review Board meetings. Initiate / monitor and track to closure of changes and CAPAs through tools like SolTraq, ServiceNow, etc. Understand SOPs, PCYC SLC. Understand existing processes in application area. Review and coordinate the draft protocols/test cases. Review validation deliverables. Support periodic reviews. Manage and monitor Audit and CAPA management Align and report to IT Compliance Lead. Co-ordinate with offshore team to share the tasks and meet deliverable timelines. #KatalystHLS || www.KatalystHLS.com ||
https://www.indeed.com/viewjob?t=computer+system+validation&jk=bd45212442c04c18&_ga=2.76602517.1835960727.1550934870-1763958782.1550934870
February 22 - National Heart Valve Disease Awareness Day || Katalyst HLS
As many as 11 million Americans have heart valve disease (HVD)—a potentially disabling and deadly disease—yet 3 out of 4 Americans know little to nothing about HVD. “Heart valve disease is a serious, yet underrecognized, disease. Combined with the fact that disease symptoms are often difficult to detect or dismissed as a normal part of aging, lack of awareness becomes dangerous.\" #ValveDiseaseDay #KatalystHLS
http://katalysthls.com/
Friday, February 22, 2019
Clinical SAS Programmer - Bridgewater, NJ - KatalystHLS.com
Responsible for creating SAS programs that map raw CDMS data to SDTM, eriodic verification of third party vendor data and SDTM. Responsible for data reconciliation between Rave extract and cumulative data transfers, programing SAS-based clinical and operational listings and reports - Bridgewater, NJ.
https://www.indeed.com/viewjob?t=clinical+sas+programmer&jk=6a64fdaf8488c450&_ga=2.168190306.2126276081.1550697987-2077807285.1533320279
Senior Regulatory Specialist - Boston, MA.
Develop the Global Regulatory Product Strategy (GRPS). Interface with the development/project teams. Represent the GRT at Regulatory Sr. Management Committees and other governance reviews. Attend Health Authority (HA) meetings as required. Lead and stimulate the Global Regulatory Team. Develop the competitive target label and Company Core Data Sheet.
https://www.indeed.com/viewjob?t=senior+regulatory+specialist&jk=07b276cbd4e59252&_ga=2.134243890.2126276081.1550697987-2077807285.1533320279
Thursday, February 21, 2019
Labeling Specialist - Rockville, MD
Overview: The Global Labeling Delivery Manager is responsible for the regulatory role in support of EU and US labeling submissions including managing the EU linguistic review process and authoring content of labeling for US SPL submissions for assigned marketed and/or pipeline products.
https://www.indeed.com/viewjob?t=labeling+specialist&jk=6eb3bf4a045f4a6d&_ga=2.231558492.2126276081.1550697987-2077807285.1533320279
Clinical SAS Programmer - Bridgewater, NJ
Responsibilities : Responsible for creating SAS programs that map raw CDMS data to SDTM. Responsible for periodic verification of third party vendor data and SDTM.
https://www.indeed.com/viewjob?t=clinical+sas+programmer&jk=6a64fdaf8488c450&_ga=2.227434846.2126276081.1550697987-2077807285.1533320279
QC, Equipment Validation consultant - Hayward, CA
Roles & Responsibilities: Supporting the implementation and maintenance of BI Fremont Instrument Maintenance program. Responsible for training site staff involved in Instrument Maintenance program, as required. Will be a point of contact when working with internal partners.
https://www.indeed.com/viewjob?t=qc+equipment+validation+consultant&jk=f37b070dd5f193e0&_ga=2.192243177.2126276081.1550697987-2077807285.1533320279
Thursday, February 14, 2019
Wednesday, February 13, 2019
Commissioning & Validation Engineer - Andover, MA
Overview: The Commissioning & Validation (C&V) Engineer is responsible for drafting and executing C&V documents and Summary Reports to ensure successful validation of all systems in the Client\'s Clinical Manufacturing Facility. Roles &Responsibilities: Draft Commissioning templates and test plans.
https://www.indeed.com/viewjob?t=commissioning+validation+engineer&jk=45f2abeb8ae0bf43&_ga=2.97606431.1857659734.1549912324-2077807285.1533320279
Quality Compliance Specialist III - Boston, MA
Roles & Responsibilities: Managed internal multi-functions teams supervise Quality staff in day to day activities. Familiar with all the regulations (GMP, EU, US etc.) and also compliances. Trained quality assurance personnel on company SOP and ISO requirements. Regulations (GMP, EU, US etc.) over 8 years.
https://www.indeed.com/viewjob?t=quality+compliance+specialist+iii&jk=9a26087651e9a3de&_ga=2.139669555.1857659734.1549912324-2077807285.1533320279
Tuesday, February 12, 2019
Monday, February 11, 2019
Friday, February 8, 2019
Senior SAS Programmer - Buffalo, NY
Writing SAS programs from instructions provided by Biostatisticians and Statistical Programmers to create CDISC data sets, tables, figures, and listings reporting and submitting the results of clinical trials for investigational medications Utilize SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH Create all files, documents, and analyses necessary to support an electronic submissions in eCTD format, including ISS/Client Work with all types of safety data and coding dictionaries (MedDRA and WHODRL) commonly used by the pharmaceutical industry
https://www.indeed.com/viewjob?t=senior+sas+programmer&jk=7ab2a191337e7ff9&_ga=2.109611590.2109980052.1549661589-2077807285.1533320279
Regulatory Affairs Associate, CMC - Richmond, CA
Responsible for the management of CMC regulatory activities for an enzyme substitution therapy program for domestic and international regulatory affairs. Involves working closely with in-house CMC teams, partners, contract manufacturing organizations, and global health authorities to ensure rapid review and approval of the CMC portions of marketing applications, amendments, supplements/ variations, and other CMC-oriented filings. Expertise with biologics and/or drug/biologic/device products is strongly preferred.
https://www.indeed.com/viewjob?t=regulatory+affairs+associate+cmc&jk=bc3b7f840cbc32a8&_ga=2.70862547.2109980052.1549661589-2077807285.1533320279
Validation Engineer - Bridgewater, NJ
Overview: Draft validation documents (VP, URS, Protocols, data migration, RTMs, VSRs, etc.) and route those for review, feedback and approval. Assist user base with execution of protocols and incident management. Review of executed protocols. Need to be Gxp focused and familiar with QA systems (LMS, LIMS, Document management).
https://www.indeed.com/viewjob?t=validation+engineer&jk=379e8e5888b782c8&_ga=2.9662326.2109980052.1549661589-2077807285.1533320279
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