- Novo Nordisk Inc. (West Lebanon, IN)
- …Are you ready to realize your potential? The Position The Deviation Leader /Coordinator is responsible for the quality and oversight of the deviation investigation ... and CAPA (corrective actions and preventive actions) management processes. The Deviation Leader is also responsible for fostering a learning culture within the… more
- BioAgilytix (Boston, MA)
- …according to GxP guidelines)Essential Responsibilities: Data Review & DocumentationPerform Quality Control (QC) technical and scientific and compliance review of ... enable life-changing, life-saving therapeutics to the patients who need them.The Technical Analyst II/III will perform responsibilities of a traditional lab analyst,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the Quality team based in Raritan, ... New Jersey. Role Overview The Lead QC Microbiology Data Reviewer is an exempt level...relevant QC documents, logbooks, SOP's and WI's. Ensure microbiological control strategy is consistent with cGMP requirements. Participate in… more
- Tris Pharma (Monmouth Junction, NJ)
- …directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, ... Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports, oversees… more
- Merck & Co. (Durham, NC)
- …to advance projects goals and deliverables related to the vaccine process Lead technical studies and author documentation associated with equipment, cleaning, ... Us Summary, Focus and PurposeThe Validation Specialist will be an energetic, technical contributor and leader with strong interpersonal, communication, and… more
- Merck & Co. (Durham, NC)
- …, Chilled water, Glycol, plant steam and condensate systems .Electrical distribution systems , Motor control systems , generators and ATS systems ... NC..- Must be able to read electrical prints, P&ID's and understand P&ID control loops. Extensive industrial experience involving utility systems with a strong… more
- Merck & Co. (Rahway, NJ)
- …individual to work in a fast-paced job that provides both technical and project management responsibility. The Specialist - Manufacturing Automation position ... will report to the Director, Engineering, Automation Lead position and will be a member of the...projects, and the automation system assets spanning production, utility systems and associated infrastructure.- Responsibilities of the Specialist -… more
- Novo Nordisk Inc. (Boulder, CO)
- …timely fashion and in a manner which meets their expectations Acts in role of lead Quality Assurance for NN Boulder Change Control process, including review and ... Department The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics, continuing...Acts as SME and local Super User for NN systems , specifically for the Change Control and… more
- Catalent (St. Petersburg, FL)
- …site. The Department has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch Release, Change Control , Client interface, Lab ... Control , as it pertains to the above validated/qualified systems and controlled documentsAuthor and approval of deviations and laboratory investigationsProvides… more
- Catalent (St. Petersburg, FL)
- …Computerized System Validation (CSV) guidelines, policies, and procedures for control systems , automation, analytical equipment, and IT applications.Ensure ... responsibility for Quality aspects including but not limited to Quality Systems , Finished Product Batch Release, Training, Internal/External Audits, Complaints, APR,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …leading investigations to ensure the written investigation report contains the technical merit and completeness according to regulatory expectations. The Deviation ... collecting necessary data and information associated with operational deviations. Will lead and facilitate root cause analysis investigations with site personnel and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …as site Radiation Safety Officer Alternate Site Security Officer to administer access control systems (card access, biometrics, key control ) Other duties ... applications/amendments as necessary: air emissions permit, Limited permit (neutralization systems ), Industrial Discharge permit (wastewater), Spill Prevention, Control… more
- Merck & Co. (Rahway, NJ)
- …the scientific community to influence the field.BPR&D includes three lab-facing technical functional areas: Process Cell Sciences (PCS), Upstream Process Development ... in contributing to one or more of the three technical functional areas mentioned above.As a Scientist in BPR&D,...process sciences to establish our company as the industry leader in next-generation biologics manufacturing.- You may also be… more
- Insmed Incorporated (Bridgewater, NJ)
- … systems , validation principles, engineering design, and statistical process control fundamentals.Experience with providing technical authoring of CMC drug ... for purposeful meetings)ResponsibilitiesResponsibilities (Essential Role Responsibilities):Responsible for being the Technical Operations liaison to the Insmed research team for… more
- Merck & Co. (Durham, NC)
- …System.Focus on ensuring facility and personnel remains in state of control based on Sterility Assurance requirements ensuring an integral process.- Lead ... management, strategy development, development/revision of standard operating procedures, compliance-based projects. Lead , facilitate and participate on cross-functional teams to collaboratively… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …external audits as SME for department and respond to audit observations. Lead technical reviews, investigations, and process improvement projects.Identify, and ... precautions and hazardous and biohazardous chemical handling.Knowledge of change control practices for major equipment, important systems , instrumentation,… more
- Catalent (St. Petersburg, FL)
- …site. The Department has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch Release, and Change Control .The QA Product ... is responsible for the overall Quality Assurance review and approval of all technical documents including but not limited to: a) change controls and associated… more
- Novo Nordisk Inc. (Wheaton, IL)
- …reach the people who need them most. At Novo Nordisk, we are the world leader in diabetes care and a major player in defeating other serious chronic conditions such ... of territory customer groups and affiliations such as IPAs, Medical Groups, Health Systems , and Local Clinics and uses this to identify business opportunities and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …projects, and equipment commissioning and validation. Key Responsibilities Develop strategy and lead the implementation of systems and processes that will ... Engineering team in the successful design, construction, and commissioning of facility systems , as well as all process and laboratory equipment. Direction and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …instructions. Develop positive relationship with the QA team, Quality Control , Information Technology, Maintenance, Manufacturing personnel, Technical Operations ... decisions. Independently resolves problems through the use of quality systems . Develop improvement ideas and independently implement associated solutions. Support… more
