- Children's Hospital Boston (Boston, MA)
- 75799BRJob Posting Title:Lab Technical Specialist I - Core Lab - $7,500.00 sign on bonusDepartment:Lab Medicine-Core ... Job Posting Category:Laboratory MedicineJob Posting Description: This Laboratory Technical Specialist I will be responsible for: + Designing, developing,… more
- Fresenius Medical Center (Lexington, MA)
- …management systems (ISO 9001, GMP, ISO 13485) as well as documenting computerized system validation and regulatory requirements (GMQ Annex 11, CFR 21 Part 11, ... PURPOSE AND SCOPE: The Senior Quality Specialist plays a pivotal role in maintaining and...audits. + Design and implement DTI (Department of Information Technology ) IT processes and controls, including IT Standard Operating… more
- Bank of America (Boston, MA)
- …+ Project Management + Relationship Building + Written Communications + Regulatory Relations + Talent Development + Technical Documentation + Workforce Diversity ... of the annual BSA independent audit as well as regulatory and partner exams by creating presentation materials and...+ As required, engage with regulators to walk through validation work + Develop test plans designed to address… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …activities from laboratory to pilot plant and commercial-scale production, ensuring smooth technology transfer and process validation . + Has full accountability ... or business processes. + Responsible for authoring relevant sections of regulatory documents, validation plans, development reports, process flow diagrams… more
- Bank of America (Boston, MA)
- …and procedures. + Strategic engagement in governance routines, issue remediation / validation , and regulatory engagement + Provides comprehensive assessment of ... to improve the control environment. + Participates in communication with regulatory agencies. + Manages performance of the team, including expense management.… more
- Medtronic (Boston, MA)
- …factors program activities, * Aiding team with preparation of usability-related regulatory documentation for pre-market approval submissions * Aid in identifying ... exploration/selection/refinement, requirements development, use-related risk identification and formal usability validation with intended users with design engineers to establish… more
- Medtronic (Boston, MA)
- …ensure systems design changes and documentation meet relevant safety and regulatory standards. Qualifications - External Must Have: Minimum Requirements Bachelors ... assigned. + Performs technical planning, system integration, verification and validation , evaluates alternatives including cost and risk, supportability and analyses… more
- Bio-Techne (Waltham, MA)
- …Laboratory Director. + Contribute to the laboratory test development optimization, validation and verification, using molecular biology techniques. + Follow the ... in accordance and compliance with all internal and external regulatory procedures. + Maintain detailed, accurate and up-to-date lab...**OR** 2. **Hold a Bachelor of Science in Medical Technology and 4+ years of experience,** **OR** 3. **Hold… more