- Hologic (Marlborough, MA)
- …on developing and implementing advanced quality engineering practices, including process validation , test method validation , and production process controls to ... (SME) for internal and third-party inspections, including those conducted by the FDA , notified bodies, and other regulatory agencies. + Quality System Compliance:… more
- Actalent (Waltham, MA)
- …will be instrumental in test method transfer, analytical test method validation , and driving continuous improvement initiatives. Your expertise will also contribute ... to test method validation , process validation , and QC testing and...of analytical method development, protein chemistry, ELISA, capillary electrophoresis, FDA regulations, and PCR. Additional Skills & Qualifications +… more
- Integra LifeSciences (Braintree, MA)
- …documentation such as product requirements, schematics, verification, and validation strategy/execution. + Coordinate and review development documentation created ... SPC programs with Manufacturing and Quality Control as a part of Process Validation and Design Transfer. + Knowledgeable of and applies statistical analysis to… more
- Integra LifeSciences (Braintree, MA)
- …documentation such as product requirements, schematics, verification, and validation strategy/execution. + Coordinate, review and approve development documentation ... SPC programs with Manufacturing and Quality Control as a part of Process Validation and Design Transfer. + Maintains knowledge of and applies statistical analysis to… more
- Cardinal Health (Mansfield, MA)
- …or testing environment, preferred + Strong knowledge of ICH guidelines, FDA regulations, Data Integrity, Quality Risk Management and other pharmaceutical regulatory ... + Working knowledge of regulatory guidelines of analytical method verification, validation , and method transfer, preferred + Experience with investigations of Out… more
- Cardinal Health (Mansfield, MA)
- …or testing environment, preferred. + Strong knowledge of ICH guidelines, FDA regulations, Data Integrity, Quality Risk Management and other pharmaceutical regulatory ... + Working knowledge of regulatory guidelines of analytical method verification, validation , and method transfer, preferred. + Experience with submission and approval… more
- Cytel (Cambridge, MA)
- …submissions, publications, annual DSUR, and exploratory analyses + Understand and follow FDA and other Health Autority regulations which affect the reporting of ... electronic submissions. + Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros +… more
- J&J Family of Companies (Danvers, MA)
- …introduction (NPI)** , including process development, work instruction creation, validation planning (IQ/OQ/PQ), and successful transfer to manufacturing. + Drive ... and review **documentation** including standard operating procedures (SOPs), specifications, validation protocols, and engineering change orders (ECOs). + Provide… more
- Abbott (Burlington, MA)
- …non-medical software, and non-product software + Support software verification and validation activities for new products and software changes in accordance with ... for final review and approval of project deliverables + Support non-product software validation by assessing the need for validation and preparing and/or… more
- Curia (Hopkinton, MA)
- …+ Oversee and implement on-floor QA + Review Executed/Unexecuted Validation /Facility Protocols/Reports + Investigate and write documentation for Unplanned ... roadmap to get from clinical to commercial Quality Systems + Support validation activities for equipment, reviewing validation documentation and recommending… more