- Catalent (Manassas, VA)
- …cross-functional areas in regulatory requirements. The Associate Director, Regulatory Affairs will review change control for potential impact on client ... Associate Director, Regulatory Affairs Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry… more
- Merck & Co. (Durham, NC)
- Job DescriptionWe are seeking a Growth and Improvement minded Quality Control Laboratory Associate Specialist that can help drive our Strategic Operating ... active ingredient, finished product and support laboratory testing for vaccines.The Quality Control Laboratory Associate Specialist participates on a team of… more
- Aequor (Seattle, WA)
- …Experience working cross-functionally Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document ... inputting and expressing Quality principles Position Reports to Jenna Walker - Associate Director, QA Training & Document Control Education: Bachelor's degree… more
- Merck & Co. (Rahway, NJ)
- …security, and copyright compliance. -Directs the development, maintenance, and control activities of CLIC terminology.Primary Activities include, but are not ... of, with input from internal stakeholders and knowledge of current regulatory requirements, the article selection, adverse event reporting, editorial, and indexing… more
- Merck & Co. (Rahway, NJ)
- …management, FMEA, design verification, design validation, statistical sampling, and control strategyExperience with regulatory fillingsWorking knowledge of ISO ... products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional… 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …discharge compliance. Develops and improves site policies, prepares and submits regulatory reports, independently track recurring regulatory reports & permitting ... referral: 0 Essential Functions Environmental & Waste Management Prepare and submit regulatory reports and filings, to include: air emissions, Tier II, Toxics… more
- Merck & Co. (Millsboro, DE)
- …Delaware seeks to add an Attending Veterinarian in the role of Associate Director.This position will have overall responsibility for oversight and administration of ... documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections… 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
- Aequor (Thousand Oaks, CA)
- …determined by the Variation Lead for reportable changes for Global Distribution control . May also translate product launch/variation strategy as determined by the ... to an executable implementation plan for launch/variation changes for Customer Facing SKU control . This role will own the execution of the implementation plan in… more
- Merck & Co. (Rahway, NJ)
- …maintaining detailed Project Plans, Risk Plans, Issue Logs, and other control artifacts.Serve as a key communication conduit, coordinating closely with Subject ... of the pharmaceutical/Life Sciences industry, including an understanding of regulatory requirements and industry trendsExperience as a consultant, preferably with… more
- American Honda Motor Co Inc (Marysville, OH)
- …professional experienceDetailed knowledge in the following areas is necessary: internal control , risk assessment and mitigation, legal / regulatory ... AHM Audit also promotes self reliance within NA operations and ensures regulatory compliance while maintaining competitive costs but with the highest quality and… more
- Merck & Co. (Durham, NC)
- …have the safest and most compliant operation around the network.EMSS has an Associate Director opening for the Teknika maintenance and Engineering team. The selected ... environment with optimized product quality and manufacturing processes and regulatory compliance. GENERAL PROFILE Provides leadership and direction through… 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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Catalent (Harman, WV)
- …limited to, purchasing, sourcing, logistics, warehousing, inventory management and control , material forecasting, functional capacity planning and sourcing, S&OP ... recovery of cost changes as appropriate.Maintain compliance with all regulatory requirements and ethical standards related to procurement.Develop and continuously… more
- Novo Nordisk Inc. (Boulder, CO)
- …and associate raw materials if applicable. Experience in quality control , analytical method, transfer, and qualification in a GDP/GLP environment with hands ... analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder,… more
- Sunrise Systems Inc (Seattle, WA)
- …Experience working cross-functionally Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document ... Job Description: Top Skills: 2+ years of Document Control & Reporting Experience, Veeva experience preferred Technical troubleshooting Self-motivated, independent,… more
- Software Galaxy Systems, LLC (Plaquemine, LA)
- …processes, quality checks, testing, sampling, and sanitation activities. Audit quality control of raw materials, packaging components, labels, and finished products ... to ensure compliance with established specifications and regulatory standards. Review, revise, and create SOPs as needed. Assist in the implementation of policies,… more
