- Aequor (Swiftwater, MN)
- Overview of the Position The Regulatory CMC Specialist will work closely with the Regulatory Site Office, Manufacturing and Supply teams, and CMC colleagues ... PA USA. This is a hybrid position. Mission The Regulatory CMC Specialist in Regulatory ... regulatory activities at Swiftwater. The incumbent manages regulatory activities linked to change controls for… more
- Merck & Co. (Durham, NC)
- …and outstanding problem solving skillsSustaining the validated state through change management and continuing validation studiesExperience with validation ... Job DescriptionWe are seeking a Growth and Improvement minded Validation Specialist that can help drive our Strategic Operating Priorities.Invent - Pursue the Most… more
- Aequor (Thousand Oaks, CA)
- …(SICAR /EN), and Change Control) under the company's quality management system procedures and ensures compliance with regulatory agency requirements. ... in Track Wise or Veeva Systems Have quality experience manager records Project management skillsThe Specialist Manufacturing is expected to own and execute under… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with the support team to prioritize and resolve tickets efficiently.Oversee change management procedures, including business engagement, impact analysis, ... treatment of multiple myeloma.Legend Biotech is seeking a Master Data Governance Sr. Specialist as part of the Technical Operations team based in Raritan, NJ. Role… more
- Aequor (Bothell, WA)
- …needs to understand shop floor activities, Good Manufacturing Practices (GMPs), electronic change management , and process automation in addition to prior ... and asset management PURPOSE AND SCOPE OF POSITION:The Benchtop Support specialist position will be responsible for providing IT support in our Digital Plant… more
- Merck & Co. (North Wales, PA)
- … filing expenses.Further develop creative thinking and problem-solving skills.Gain experience in change management , project management and people ... Job Description Position Description: Senior Specialist , Financial Planning & Analysis Our company's mission...guidance of the Associate Director who supports the Global Regulatory Affairs & Clinical Safety (GRACS) and Quality Assurance… more
- Merck & Co. (Durham, NC)
- …system(s) remain in a validated status (eg, problem and incident management , change control, periodic review, investigations, backup/restore, System Use ... and laboratories to ensure compliance with company policies, procedures, and regulatory expectations. Be involved in all quality-related activities for computerized… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Inc. (NNI). At Novo Nordisk, your skills, dedication and ambition will help us change lives for the better. In exchange, we'll offer you an opportunity to work ... crafting meaningful reports, leveraging data analytics, and supporting project management activities across the legal department. Relationships Reports to Lead,… more
- Aequor (West Greenwich, RI)
- …8-5 PM What is the working environment for this role? Role supports quality management systems, office based, EW will be supporting recall regulatory reporting ... is comfortable working remotely and able to work independently, understanding quality management systems (QMS systems), looking for a candidate who has experience in… more
- Houston Methodist Hospital (Houston, TX)
- …work autonomously as defined by the Nurse Practice ActActs as effective change agentDemonstrates proficient time management skillsExpert knowledge of Nursing ... for improvement. Provides guidance to staff in clinical project development and management , using the PDCA process and supporting the Pathway to Excellence/Magnet… more
- West Pharmaceutical Services (Exton, PA)
- Sr. Specialist , Regulatory Project Management (Evergreen Posting) Requisition ID: 67683 Date: Nov 14, 2024 Location: Exton, Pennsylvania, US Department: ... environment and planet through our sustainability efforts. **Job Summary:** This Senior Specialist , Regulatory Project Management (RPM) role is responsible… more
- LSI Solutions (Victor, NY)
- …state-of-the-art devices. After all, our customer is ultimately the patient. JOB TITLE: Regulatory Specialist (Labeling) - Days 8:00AM to 5:00PM SALARY RANGE: ... LOCATION: Onsite at LSI Solutions in Victor, NY JOB SUMMARY: The Regulatory Specialist applies her/his experience, knowledge, organization skills, and… more
- Abbott (Sylmar, CA)
- …CA currently has an on-site opportunity for a **Senior Regulatory Affairs Specialist ** with our Cardiac Rhythm Management division. This position leads the ... departmental and organizational objectives. + Creates, reviews and approves change orders. + Acts as a regulatory ...contractors, and vendors. + Provides mentoring and leadership to Regulatory Specialist I and II team members… more
- Integra LifeSciences (Salt Lake City, UT)
- …problem solving and communication skills. + Strong understanding and capability in change management , database analytics and development including data uploads, ... and making headway to help improve outcomes. The Senior Specialist , Regulatory Data Analyst is a seasoned...leading the ongoing development, maintenance, and expansion of the Regulatory Information Management System (RIMS), as well… more
- Guthrie (Sayre, PA)
- …proficient in policy development and maintenance, including knowledge of the internal policy management system. The regulatory compliance specialist must be ... MAIN FUNCTION: This position will be responsible for the oversight of regulatory requirements, including policy development and management , within the entity… more
- Adecco US, Inc. (Swiftwater, PA)
- Adecco Healthcare & Life Sciences is hiring a contract hybrid Regulatory Affairs Specialist for our Pharmaceutical Manufacturing partner in Swiftwater, PA. The ... upon meeting eligibility criteria Overview of the Position The Regulatory CMC Specialist will work closely with... regulatory activities at Swiftwater. The incumbent manages regulatory activities linked to change controls for… more
- Bank of America (Charlotte, NC)
- …Oral Communications + Written Communications + Analytical Thinking + Change Management + Presentation Skills + Regulatory Compliance **Shift:** 1st shift ... Global Regulatory Reporting Observation Management Sr. Specialist Charlotte, North Carolina **Job Description:** At Bank of America, we are guided by a… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** Senior Regulatory Affairs Specialist - hybrid - Covington, Georgia Urology and Critical Care (UCC) is an established and trusted ... optimize the urine drainage process in the Acute Care Hospital setting. The Senior Regulatory Affairs Specialist is responsible for preparation of US and CE… more
- California Energy Commission (Sacramento, CA)
- Program and Regulatory Specialist ELECTRIC GENERATION SYSTEM PROGRAM SPECIALIST I $9,832.00 - $12,300.00 per Month Final Filing Date: 11/21/2024 Job ... of a Program and Project Supervisor, the Program and Regulatory Specialist will support Special Project's activities...fuel and vehicle types to meet the state's climate change and public health policies. The MQs for this… more
- Kelly Services (Sunnyvale, CA)
- …limited to software validation and data entry + The Regulatory Affairs Process Specialist will review change workflows in the Agile PLM system and perform ... **Kelly Science and Clinical is hiring a Regulatory Affairs Process Specialist to work...administrate UDI Management software + Understand UDI change management **The essential requirements of the… more
