- Merck & Co. (Rahway, NJ)
- …. - Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address clinical supply related topics ... develops mitigation strategies for review with clinical partners and senior leaders.- - Works directly in the SAP system...relationship management. - Technical Proficiency: familiarity with supply chain systems and software ( eg SAP or Oracle) and… more
- Merck & Co. (Baton Rouge, LA)
- Job DescriptionThe Automation Senior Specialist will support startup, commissioning, and qualification on capital projects in support of our company's Animal ... training, day to day operations support. T he Automation Senior Specialist will work closely with engineers,...systems and develops strategies to optimize and ensure quality and stability of automation systems through… more
- Merck & Co. (Rahway, NJ)
- Job Description Summary, Focus and Purpose The Senior Engineer in Device Technology is a key member of our Device Development & Technology Team, with ... manner are at the core of this position. The Senior Engineer will routinely face competing priorities, and must...including those related to Combination Products and Drug Delivery Systems . The role includes leading, enabling or consulting in… more
- Novo Nordisk Inc. (Durham, NC)
- …the pharmaceutical or medical device field Demonstrated expertise in Regulations & quality systems (eg, commercial product disposition, DV/CAPA, Change Control, ... of this role will be Audits and Inspections. The Sr . QA Area Specialist will host internal...& improvement of Quality processes. Relationships Manager, Quality Assurance. Essential Functions Ensures plant systems … more
- Novo Nordisk Inc. (Durham, NC)
- …preferably in the pharmaceutical industry Demonstrated expertise in Regulations & quality systems (eg, commercial product disposition, DV/CAPA, Change Control, ... with the ability to train on Days. Relationships Manager, Quality Assurance. Essential Functions Ensure plant systems ...Manager, Quality Assurance. Essential Functions Ensure plant systems batch release & relevant quality processes… more
- Merck & Co. (Rahway, NJ)
- …ensure high quality data and timely and complete synchronization between systems . Acts to resolve all issues and discrepancies as data stewards responsible for ... and change control for SAP BPC. The LPT COE Sr . Specialist is responsible for supporting BPC...are not limited to, the following: Strong knowledge of Systems Applications and Products in Data Processing, Business Planning… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe regulatory operations senior specialist supports cross-functional or departmental projects related to regulatory operations. This role will ... and information to meet internal and external requirements, maintain regulatory systems and technologies to support the operational needs of the regulatory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking an Senior CQV Specialist as part of the Commissioning and Qualification team based in Raritan, NJ. Role OverviewThis position will be ... management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production… more
- Novo Nordisk Inc. (Seattle, WA)
- …establish Novo Nordisk as a frontrunner in the cardiometabolic care market. The Senior Ecosystem Portfolio Specialist is responsible for achieving sales targets ... services, ensuring adherence to approved guidelines. Relationships Externally, the Senior Ecosystem Portfolio Specialist maintains relationships with physicians,… more
- Aequor (Thousand Oaks, CA)
- …supplier investigations/etc. Preferred experience managing in Track Wise or Veeva Systems Basic project management skills required.The Specialist Manufacturing ... Event Notifications and Investigations (SICAR /EN), and Change Control quality records. This Specialist Manufacturing will act...robust Deviations / CAPA process - Build and present quality records summaries for Senior Management review.… more
- Actalent (Santa Clara, CA)
- Job Title: Quality Systems Specialist Job Description In compliance with FDA, European MDD/MDR & ISO regulations, the Quality Systems Specialist ... Essential Skills + Audit + CAPA + NCR + Quality Systems + Managing Audits (Internal &...self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for… more
- J&J Family of Companies (Santa Clara, CA)
- …California, United States of America **Job Description:** Johnson & Johnson is hiring for a ** Sr . Quality Systems Specialist - Shockwave Medical** to ... Overview** In compliance with FDA, European MDD/MDR & ISO regulations, the Quality Systems Specialist will perform work under general supervision. The… more
- The Boeing Company (Colorado Springs, CO)
- …growth. Find your future with us. **Boeing Defense, Space and Security (BDS)** is seeking a Senior Quality Systems Specialist (Level 4) to support the ... join us - your future is built here! A senior -level Quality Specialist will develop... will develop and maintain the Colorado Springs Ground Systems Quality Management System, lead process councils,… more
- SHI (Piscataway, NJ)
- **Job Summary** The Quality Systems Specialist - PE will assist the Quality & Compliance team in maintaining the company's Quality Management System ... M/F/Disability/Protected Veteran Status Refer a friend to this job (https://careers-shi.icims.com/jobs/18976/ quality - systems - specialist /job?mode=apply&apply=yes&in\_iframe=1&hashed=-336032949) **Need help finding the… more
- Integra LifeSciences (Princeton, NJ)
- …set new standards of care. As part of Integra's Business Systems Team, the Quality Systems Senior Specialist is a seasoned professional with complete ... device industry. 4-5 years of proven experience in an analytical or business/ quality systems environment. + Technical knowledge of Trackwise Digital system… more
- Danaher Corporation (Coralville, IA)
- …that safeguard and improve human health. This position is part of the Quality Assurance, Therapeutics Gene Editing (Tx) department located in Coralville, Iowa and ... opportunity to: + Lead IDT Tx's Change Control, Internal Audit and Quality Events/CAPA programs + Responsible for implementing, maintaining and improving IDT Tx's… more
- Abbott (Livermore, CA)
- …are helping address some of the World's greatest healthcare challenges. As the Senior Document Control and Training Specialist , you are responsible for ensuring ... processes associated with Quality Training System are in compliance to internal and...Quality Assurance. + Identify gaps in Documentation and Systems and take necessary actions to correct. + Ensure… more
- CVS Health (Franklin, TN)
- …will do** + Executes both routine and non-routine business support tasks for the Sr Quality Specialist area under limited supervision, referring deviations ... support. + Acts as a subject matter expert on Quality Specialist workflows, policies, systems ...reporting overall results, and making recommendations regarding training needs, quality controls, and procedures to senior management.… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …Summary:** The Sr . Quality Associate I/II will primarily serve as a Quality Systems technical specialist as part of the QA Fractionation business ... : 1st - M-F 8:00am - 4:30pm ** Sr . Quality Associate I/II -...as author, reviewer, approver, administrator or coordinator) in all quality systems such as Change Control, Discrepancy… more
- L3Harris (Northampton, MA)
- …land, sea and cyber domains in the interest of national security. Job Title: Sr . Specialist , Systems Engineering Job Code: 21552 Job Location: Northampton, ... Schedule: 9/80 Job Description: We are looking for a Senior Specialist System Engineer to synthesize and...technical contractual obligations are fulfilled. + Ensure adherence to Quality Systems Manual and applicable Standard Work… more
