- Nesco Resource (Burlington, MA)
- …Strong understanding of data integrity, good documentation practices, and computer system validation . Familiarity with regulatory standards such as 21 CFR Part ... routing, uploading, archiving, and distribution, along with assisting in system validation and audits. The position involves maintaining compliance with quality… more
- Dana-Farber Cancer Institute (Boston, MA)
- The Regulatory Affairs Specialist (RAS) positions provides advanced expertise and regulatory support to 600+ investigators and research staff members at ... review of select protocol and monitoring processes prior to IRB review. The Regulatory Affairs Specialist (RAS) positions are critical to successfully achieving… more
- Fresenius Medical Center (Lawrence, MA)
- …related activities, including Quality System Audits, labeling reviews, and verification/ validation reviews. + Maintain corporate regulatory files. **Education ... **Position Summary:** The incumbent will manage the regulatory process, both domestic and international markets, for NxStage Medical, Inc. products and provide … more
- 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
- Prime Therapeutics (Boston, MA)
- …and drives every decision we make. **Job Posting Title** Pharmacy Rebate Specialist , Government - Remote **Job Description Summary** This position is responsible for ... contact for manufacturers to answer/resolve rebate questions. + Conducts quality validation and approval of claim files. **Additional Preferred Qualifications** +… more
- Eurofins (Cambridge, MA)
- …problems/issues. + Conducts work in compliance with cGMP/GLP, safety and regulatory requirements. + Writing technical reports for functional area + Independently ... industry practices and standards. + Experiences on method development and validation for synthetic molecule products + Strong computer, scientific, and… more
- Commonwealth Care Alliance (Boston, MA)
- …Interdepartmental stakeholders include but are not limited to: quality; regulatory affairs/compliance; clinical, operations, pharmacy, dental, reporting, and member ... and external audits of grievance and appeals processes as well as data validation activities, as needed. - Supports the maintenance of updated data in… more
- Orchard Therapeutics (Boston, MA)
- …diagnostic assays, including, where applicable, companion diagnostic (CDx), development, regulatory approval and commercialisation is planned and executed within ... clinical team to provide key expertise in study specific, potentially specialist , bioassay set-up and implementation. Key elements and responsibilities . Serve… 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...as necessary. + Stay updated on industry standards and regulatory requirements related to quality management systems in IT.… 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
- 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
- Takeda Pharmaceuticals (Cambridge, MA)
- …or business processes. + Responsible for authoring relevant sections of regulatory documents, validation plans, development reports, process flow diagrams ... analytical development, drug product development, manufacturing, quality assurance, and regulatory affairs, to develop and implement effective process engineering… more
- Bank of America (Boston, MA)
- …and procedures, as well professional standards set forth by industry and regulatory institutions. Responsibilities include but are not limited to: + Subject matter ... of the annual BSA audit work as well as regulatory and partner exams by creating presentation materials and...assurance reviews of core audit activities ie audits, issues validation , audit plan documentation and coverage, and other special… more
- Bio-Techne (Waltham, MA)
- …Laboratory Director. + Contribute to the laboratory test development optimization, validation and verification, using molecular biology techniques. + Follow the ... + Operate in accordance and compliance with all internal and external regulatory procedures. + Maintain detailed, accurate and up-to-date lab records. + Use… 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
