- Merck & Co. (North Wales, PA)
- Job Description Position Description: Associate Director, Regulatory Affairs Liaison- Vaccines and Infectious Disease The Regulatory Affairs Headquarters ... as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and Control (CMC) as well as other… more
- Merck & Co. (Millsboro, DE)
- …supply to customers and patients on time, every time, across the globe.The Quality Control (QC) Associate Specialist, with Guidance from the QC Manager, ensures ... of QC tests, and review and release of antigen and seed batches. The QC associate specialist must adhere to regulatory and site policies and procedures governing… more
- Aequor (West Greenwich, RI)
- …PHD. Ideally looking for candidates with at least 2 years of an associate degree combined with 2 years of General lab experience/lab background, GDP/GMP experience ... At all times, comply with safety guidelines, cGMPs/CFRs and other applicable regulatory requirements. Shift: Tuesday - Friday shift schedule. Skills: Previous lab… more
- Merck & Co. (Durham, NC)
- …of atypical events including accessing product impact for events.Ensure proper control of materials via product investigationsAssist regulatory groups by ... with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract… more
- Merck & Co. (Durham, NC)
- …with our core principle of Safety First and Quality Always.The Associate Director, Engineering/Maintenance will support a new drug substance manufacturing ... unit operations and associated clean utilities and process equipment.- The Associate Director will manage tactical and strategic process, equipment, and… more
- Merck & Co. (North Wales, PA)
- …or the device constituent of a combination product.Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical ... Device and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality Engineering & Quality Assurance is responsible for… more
- Aequor (Thousand Oaks, CA)
- …processes Own/ provide support Deviations/CAPAs, root cause assessments, and change control records Outputs Ensure product supply using a GDP compliant distribution ... or Business experience preferably in the biotechnology or pharmaceutical industry OR Associate 's degree and 6 years of Life Science or Business experience preferably… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …playing a supportive role in ensuring adherence to Project objectives, budget control and departmental collaborations. Work is escalated if outside of scope of ... strong knowledge of GMPs and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items from time to time.Has… more
- Merck & Co. (Rahway, NJ)
- …reliance on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the BDC ... support GMP clinical production. -Execute and develop appropriate system validation, change control , and testing documentation in partnership with project CQV and IT… more
- Insmed Incorporated (Bridgewater, NJ)
- …quality systems, validation principles, engineering design, and statistical process control fundamentals.Experience with providing technical authoring of CMC drug ... substance sections of regulatory filings and dossiers.Sound awareness of Regulatory , Quality Assurance, and cGMP requirementsHigh energy, innovative "can do"… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …cross functional assistance for PGC, Learning Management System (LMS) and Regulatory , as needed. ResponsibilitiesEditorial Review of Materials Review and consult ... who interact with PMRT in accordance with the AOP; maintain training documentsQuality Control of all PMRP Material Access review material through the PMVP Confirm… more
- Merck & Co. (Rahway, NJ)
- …potency data in context of broader process and product development, control strategy, and specifications-setting.-Deep working knowledge of regulatory guidance ... will be directly responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey. -The position is accountable for… more
- Merck & Co. (Durham, NC)
- …and approval of system commissioning and qualification documents, change control , automation incidents, Quality Notifications (QNs), and other key automation-related ... processesProviding direct support for regulatory inspections and audits and other validation activities by...Technical organizations to resolve complex problems. Responsible for Fermentation control Systems specific to areas of Seed and Production… more
- Merck & Co. (Durham, NC)
- …maintaining accurate documentation of activitiesUndertaking SAP transactions and change control activities including spare part lists and preventative maintenance ... handling unit maintenance, operations, and reliability)Automated systems (eg, Distributed Control System, Programmable Logic Controllers)Maintenance equipment (eg, tools, calibration… more
- Merck & Co. (Durham, NC)
- …written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) ... Equipment (eg washers, autoclaves, tube welders/sealers).Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics).Clean-In-Place (CIP)… more
- Merck & Co. (Rahway, NJ)
- …escalates performance issues and training-needs to CRA (Clinical Research Associate ) manager and/or functional vendor and internal management as-needed.Performs ... Quality control visits as required.Leads local study teams to high...the TA Head or CRD.Requires strong understanding of local regulatory environment.-Strong scientific and clinical research knowledge is required.-Strong… more
- Merck & Co. (Durham, NC)
- …written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) ... 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 knowledge… more
- Aequor (Melville, LA)
- …- 6&plus months contract - Onsite roleResponsibilitiesThe QC Stability/Lab Technician Associate is responsible for assisting with the company's stability program for ... stability program and to support the QC Laboratories with sample receipt/ control and glassware maintenance.For the stability department, this includes the… more
- Merck & Co. (Durham, NC)
- …written documentation of activities. Accountable for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) ... compression stills, compressed gas systems) Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics)- Clean-In-Place… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …report contains the technical merit and completeness according to regulatory expectations. The Deviation Investigator-Writer will be responsible for initiating ... ongoing consistency for investigation reports that will stand alone during regulatory inspection through close collaboration with Operations and Quality teams Lead… more
