- Merck & Co. (North Wales, PA)
- …Owner for one or more of the QMS processes managed under GRACS(Global Regulatory Affairs & Clinical Safety) Quality &Compliance.Establishes and maintains ... Action, Problem Solving Therapy, Process Improvements, Professional Integrity, Project Management, Quality Assurance Processes, Quality Management, … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … quality mindset with Medical Affairs .Support the Sr. Director's Medical Affairs Quality strategy by partnering with members and business stakeholders for ... GxP Quality representatives, and act as the Quality Assurance point person for all GxP... and compliance.Evaluate risks impacting GxP compliance within Medical Affairs , driving ongoing improvements to meet regulatory … more
- AUROBINDO (Dayton, OH)
- …team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations ... a healthier world to live in.Job OverviewServe as technical expert on Quality Control instrumentation and methods. Train and mentor junior chemists. Troubleshoot… more
- AUROBINDO (Dayton, OH)
- …team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations ... operational problems and inefficiencies and recommend resolutions.Participate in any regulatory inspections from various organizations such as FDA, Environmental… more
- Merck & Co. (Philadelphia, PA)
- …Management Process, Manufacturing Quality Control, Organizational Performance Management, Quality Management, Regulatory Affairs Compliance, ... Report, Audits Compliance, Communication, Compliance Remediation, Customer Satisfaction, Data Quality Assurance , Document Control Systems, Electronic Common… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- ** Quality Assurance & Regulatory Affairs Compliance Specialist** **Position Summary** Catalent, Inc. is a leading global contract development and ... most difficult development and manufacturing challenges. The ** Quality Assurance & Regulatory Affairs Compliance Specialist** is responsible for … more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …ideal place to build your career.Job SummaryDirects the activities of the Quality Assurance and Regulatory Affairs department. Ensures the quality ... and regulatory systems are effectively implemented and maintained.Essential Functions + Pre-market approval of new and modified medical devices in domestic and international markets. + Post-market surveillance and medical device reporting in domestic and… more
- University of Colorado (Aurora, CO)
- …healthcare-related experience. + Two (2) - four (4) years of related quality assurance and regulatory affairs experience in a clinical laboratory. + ... audits to ensure compliance. + Oversees quality assurance in compliance with strict regulatory standards...through audits and occurrence reports to the Director of Regulatory Affairs and/or Quality Manager,… more
- GE HealthCare (Waukesha, WI)
- … Leadership Program Internship is for graduate students seeking a career in Quality Assurance and Regulatory Affairs . GE Healthcare Quality & ... of project experience in one or more of the following areas: Quality Assurance , Regulatory Affairs , Product Surveillance, Complaint Handling, Corrective… more
- Cambrex High Point (High Point, NC)
- …background/leadership in GXP/QA/ regulatory compliant pharmaceutical laboratory environment or Quality Assurance / Regulatory Affairs role (prefer ... and/or lead project and site risk assessments relative to quality management systems and impact to client projects/ regulatory...Requests, and Deviations in coordination with the Associate Director, Quality Assurance + Author and Revise … more
- Abbott (Atlanta, GA)
- …field + Eight (8) years of Quality Systems, Quality Assurance and/or Regulatory Compliance/ Affairs experience in medical device manufacturing or ... quality system requirements and how they impact product quality and regulatory compliance. + Represents the site within Abbott through Corporate based… more
- Lilly (Indianapolis, IN)
- …following associated fields: TSMS, Production, Quality Assurance , Quality Control, Engineering, or Regulatory Affairs . **Additional ... better for people around the world. **Responsibilities:** The Associate Director - Quality Assurance (QA) API External Manufacturing is responsible for managing… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …required content. Support regulatory impact assessments for change controls and other Regulatory Affairs / Quality Assurance items from a review and ... a **maker of possible** with us. **Job Overview** As a Staff Regulatory Affairs Specialist, you will play a crucial role in supporting Medication Management… more
- Danaher Corporation (Miami, FL)
- …you also possess previous experience in: . Prior internship or coursework in regulatory affairs or quality assurance . Understanding of FDA, EMA, or ICH ... career. Learn about the Danaher Business System which makes everything possible. The Regulatory Affairs Intern will gain hands-on experienc e in regulatory… more
- BD (Becton, Dickinson and Company) (Cayey, PR)
- …Biochemistry, Microbiology Biology, and Engineering) and a minimum of five years of quality assurance / regulatory affairs experience in a ... Systems Manager is responsible for maintaining the internal Quality Audit program in compliance with the regulatory...and product disposition with the Planning Group and the Quality Assurance Associates and Technicians in order… more
- Kadlec (Kennewick, WA)
- …be substituted for educational requirements. + 3 years Relevant experience in research quality assurance , regulatory affairs , or clinical research/study ... **Description** The Quality Assurance (QA) Specialist coordinates and...+ Significant education in the field of clinical research, regulatory affairs or compliance can be substituted… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …Minimum of 15 years of pharmacuetical industry experience in a Quality Assurance and/or Regulatory Affairs function including experience in manufacturing ... quality . The Sr. Director leads and mentors quality assurance and quality control...+ Minimum 5 years managerial experience in a pharmaceutial quality / regulatory affairs environment. Preferred Skills/Qualifications:… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …in a regulated medical device/IVD industry employment position such as post-market surveillance, quality assurance , regulatory affairs , clinical ... a regulated medical device/IVD industry employment position such as post-market surveillance, quality assurance , regulatory affairs , clinical affairs … more
- GE HealthCare (Bellevue, WA)
- …Engineering, Computer Science or equivalent. + Minimum 10 years' experience in Quality Assurance / Regulatory Affairs . + Minimum of 2 years' experience ... Description Summary** This people-leader position will be responsible for Quality Assurance activities in support of the...quality management system for the business and driving Quality metrics. Ensures quality and regulatory… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …as Marketing, R&D, Design Assurance Engineering, Software Engineering, Systems Engineering, Regulatory Affairs , Quality Assurance , external vendors, ... **Job Description Summary** Specialist, Senior Specialist, Medical Affairs is an integral member of Medical and...of design history files, clinical trial master file(s) supporting regulatory submission registrations and updates of the BD products.… more
