- Merck & Co. (Rahway, NJ)
- …audits and process audits, both domestic and abroad to maintain a strong internal control environment at our company.On occasion, the incumbent will be ... summaries of issues and reports which accurately describe identified control concerns, associated risks, and appropriate recommendations.Participate in-department projects… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …training, CVs, JDs- Collect, store and maintain all auditable documentation as per DSI Internal control - Support the Head Global QA strategy and operations to ... for meetings and a wide array of audiences- Edits and produces advanced internal and external communications; acts on behalf of an executive for certain decisions… more
- BioAgilytix (Durham, NC)
- …post-market product changes and decision on appropriate mechanism for change control (eg internal documentation, notification of change, supplemental ... requirements of key regulatory agenciesCoordinates regulatory issue resolution using internal resources, regulatory agencies, and outside consultants as neededRegulatory… more
- Novo Nordisk Inc. (Boulder, CO)
- …for overseeing a team of QA Specialists ensuring the tactical execution of the internal and external (CMO) change control and deviation processes at NN Boulder, ... Acts in role as primary process SME for the Change Control process at NN Boulder Support internal and external (CMO) stakeholders with issue resolution in a… more
- Eisai, Inc (Exton, PA)
- …cross-functionally with Support Operations, Facilities, R&D, Quality Assurance, Quality Control , Validation, and other internal and external functions ... commercial manufacturing.Coordinate equipment maintenance, calibration, and validation with appropriate internal departments.Perform review and revision of SOPs and master… 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) ... Seeks ideas and information on how to improve customer service involving internal and external customers. Applies knowledge of the overall supply chain to… more
- Merck & Co. (Rahway, NJ)
- …Organics Pilot Plant (SSO): - The SSO uses an Emerson DeltaV Distributed Control System.- The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in ... (PR&D) organization.- The pilot plant's mission is to serve as PR&D's internal node for small molecule drug substance clinical manufacture, and as preferred… more
- Merck & Co. (North Wales, PA)
- …contracts and agreements in the Public Sector (inclusive of Centers for Disease Control and Prevention , United States Department of Veterans Affairs , and ... Department of Defense segments).-This position partners with key internal stakeholders, including Brand Marketing, Portfolio Marketing, Global Market Access &… more
- Catalent (St. Petersburg, FL)
- …aspects related to Quality Systems, Finished Product Batch Release, Change Control , Client interface, Lab Investigations, Deviations, Complaints, etc. The focus of ... service, with the highest integrity, in partnership with Catalent St. Petersburg's internal technical departments. This position is expected to serve as a… more
- Insmed Incorporated (Bridgewater, NJ)
- …qualification, calibration, PM, etcReview and approve deviations, CAPAs, SOPs and Change Control related to QC Lab and operationsPartners within QA team to execute ... of Insmed Person In Plant (PIP).Responsible for QA representation in Design Control Process for medical device products and combination products.Lead the quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and optimization of organization resource allocation. Responsible for managing internal and external strategic collaborations to optimize Operational Excellence and ... the planning and execution of CMR initiatives; actively participating in multiple internal cross-functional teams to ensure the effective delivery of all functional… more
- Merck & Co. (Rahway, NJ)
- …and can represent the Company in forums on their area of expertise (both internal & external). Primary activities include, but are not limited to: May manage a ... of the Company and compliance with all governing regulations.Responsibility for Quality Control functions including oversight for product testing, as well as other… more
- Merck & Co. (Rahway, NJ)
- …new solutions or enhancing existing solutions in Guest Management, Physical Access Control , and Video Surveillance products within the Site Security product line to ... project backlog.Develop expertise in Integrated Guest Management, Physical Access Control , and Video Surveillance, and the core business processes… more
- Merck & Co. (Rahway, NJ)
- …laboratory experiment design and execution, technology transfer to internal and external manufacturing sites, process validation, manufacturing investigations ... scientific and administrative department direction and working in conjunction with internal and external program partners, this individual will support late stage… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …with plant audit ready status efforts for assigned areas and participate in internal and external audits as SME for department and respond to audit observations.Lead ... changes within quality systems.Assure equipment maintenance and calibration, and internal audits are performed.Prepare SOPs and specifications. Write memos, reports,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary This role is responsible to work with DS internal customers, R&D Procurement team members and Vendors to support the generation, ... payment schedule scope negotiation through to contract execution. Coordinate with internal customers to understand their procurement needs and provide timely… more
- Merck & Co. (Millsboro, DE)
- …as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections (USDA, DEA, DNREC, etc.) of animal ... state regulatory requirements for animal welfare, management of controlled substances, quality control testing according to GMP standards, and emissions control … more
- Merck & Co. (Rahway, NJ)
- …with subject-matter experts on the DD team and members of internal cross-functional product development teams from concept through product launch.- Additionally, ... development; manufacturing process development, qualification, and validation; and, design control and risk management techniques to positively support and influence… more
- Eisai, Inc (Nutley, NJ)
- …controls.Monitor and test IT compliance controls for effectiveness.Remediate control deficiencies and investigate potential unlawful actions.Oversee system data ... program, including JSOX compliance.Maintain accurate compliance documentation and advise control owners.Assess risk, evidence adequacy, and remediate findings.Evaluate new… more
- Novo Nordisk Inc. (Baltimore, MD)
- …(NNI)-approved solutions Demonstrates professionalism and a customer-focused approach with internal and external stakeholders by actively listening, identifying and ... customers and patients' needs, and keeping commitments Develops and sustains internal relationships by collaborating across functions (eg Market access, Educators,… more
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