- Merck & Co. (Durham, NC)
- …of issuesUtilizes monitoring, performance tools and systems to ensure product quality , drive Right First Time and compliance standardsAble to develop and ... of the Quality System Model and relationships across its componentsUnderstands quality systems relevance and importance when developing quality policies,… more
- Aequor (Seattle, WA)
- …quality products. The role will benefit from a strong understanding of working within quality document systems and managing the on-time document ... simultaneously. Demonstrated proficiency in MS Project, PowerPoint, Excel, Word, and Document Managements Systems (Veeva Vault preferred). Experience in data… more
- Catalent (St. Petersburg, FL)
- …responsibility for Quality aspects including but not limited to Quality Systems , Finished Product Batch Release, Training, Internal/External Audits, ... committed to a Patient First culture through excellence in quality and compliance , and to the safety...and requirements to address data integrity gaps for GxP systems and assuring compliance for the site.Identify… more
- Catalent (Manassas, VA)
- …years of experience in regulated environment is required. Knowledge of GMP and Quality systems ; Ability to read and follow documents (Standard Operating ... appropriate details; Report any housekeeping issues that need attention. Document all areas of non- compliance and ensure...any other standard Catalent complies with; Responsible for ensuring compliance to FDA and cGMP standards for Quality… more
- Cynet Systems Inc. (Cincinnati, OH)
- …required. A bachelor's degree is preferred. Experience with publication management systems (eg, PUBSRAT, PubPro) is highly preferred. Basic understanding of research ... methodologies (in clinical/health preferred) Knowledge in regulatory and/or compliance in health care industry (eg, clinical research, trials, health outcomes… more
- Merck & Co. (Rahway, NJ)
- …to prepare Standard Operating Procedures (SOP) and cGMP documents.Experience with Quality SystemsExperience in supporting compliance investigations and change ... projects, and the automation system assets spanning production, utility systems and associated infrastructure.- Responsibilities of the Senior Specialist -… more
- Merck & Co. (Rahway, NJ)
- …Engineer will be responsible for evaluating, recommending, implementing and supporting systems in the manufacturing and lab print environment including label and ... document printing using infrastructure applications such as HPOM, LRS...perform lifecycle management of bar code printers and software systems . The engineer will also look to strengthen the… more
- Merck & Co. (Rahway, NJ)
- …projects, and the automation system assets spanning production, utility systems and associated infrastructure.- Responsibilities of the Specialist - Manufacturing ... Operations (GWES) :- The Automation specialist will help to support several automation systems across the Rahway Site including ABB Distributed Control Systems ,… more
- Merck & Co. (Durham, NC)
- …commissioning and qualification through licensure and ramp up. Participate in document design activities working alongside operations team members to develop ... sample and other materials as required to appropriate laboratories, coordinating with Quality and Logistics as required. Performs housekeeping in all work areas.… more
- Aequor (Thousand Oaks, CA)
- …and Logistics Service Providers - Partner with clinical site staff and Quality to document , investigate, and communicate decisions concerning distribution ... MS suite skills, with an emphasis on Outlook and Teams Experience with Quality Management Tracking Systems (QMTS) Smartsheet and SharePoint knowledge General… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …simultaneously Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements. Drive continuous improvement Other duties ... shooting and resolving complex scientific / technical problems Develops and evaluates quality processes and system standards to ensure compliance with applicable… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the oversight, performance and management of CROs and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of ... and execution (from planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the oversight of and… more
- Merck & Co. (North Wales, PA)
- …the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity.Lead development and execution of detailed, ... and response to health authority questions per established business processes and systems .Collaborate with partner groups in critical review of submissions to ensure… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …, instrumentation, and computerized systems .Knowledge of quality systems including exception management, change control, document control.Knowledge of ... investigations, and process improvement projects.Identify, and oversee changes within quality systems .Assure equipment maintenance and calibration, and internal… more
- TalentBurst, Inc. (Mead, CO)
- …Mead, CO Duration: 12 Months with possible extension The primary function of the Document Control /Specialist is the quality of the data controlled and support ... to project teams and compliance with Engineering Services. Responsibilities: This role will be... document registers and workflows. Experience in implementing document management systems to support an electronic… more
- DivIHN Integration Inc (Irving, TX)
- …Perform evaluation of engineering documentation supporting identified projects. Resolve document control issues and discrepancies. Ensure compliance to ... 0-3 Yrs Experience Preferred Experience: Knowledge and proficiency of electronic document control systems . Knowledge of engineering documents and change… more
- Sunrise Systems Inc (Summit, NJ)
- …quality products. The role will benefit from a strong understanding of working within quality document systems and managing the on-time document ... Job Title: Data Stewardship and Compliance Business Analyst Job ID: 24-02392 Location: Summit...Demonstrated proficiency in MS Project, PowerPoint, Excel, Word, and Document Managements Systems (Veeva Vault preferred). Experience… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to help the team, in a manner consistent with safety policies, quality systems , and cGMP requirements. Support manufacturing investigations, create/revise ... and assign individuals their daily production task to execute and ensure compliance and successful completion of work-related tasks. Work closely with operations… more
- DCS Corp (Bedford, MA)
- …include system design/design feasibility and state-of-the-art assessment. Produce architectures, document planned and existing systems , determine deficiencies, ... DCS Corp has an exciting opportunity for a Senior Systems Engineer providing support to the Air Force Life...technical accuracy and conformance to requirements, specifications, regulations and quality control to ensure compliance with ASME… more
- Computer World Services (CWS)Corporation (Washington, DC)
- …MemorandumsIdentify, assess, and prioritize identified risksCollect evidence, artifacts, and document findings to support conclusionsReport on compliance with ... implementing the processes and methodologies to assess internal and external/third-party systems , and provide an accurate accounting and tracking for shortcomings… more
