- Verista (Woburn, MA)
- …new skills and learn from our experiences to enhance our collective expertise Validation Lead (Laboratory) Analyst Responsibilities: + Perform validation ... from vendor manuals + Perform method transfers + Independently lead the Client through the Validation Lifecycle...+ Independently lead the Client through the Validation Lifecycle required for their identified equipment Requirements +… more
- Bristol Myers Squibb (Devens, MA)
- …biology assays in the Quality organization. + Responsible for transfer and validation of methods in the commercial environment in compliance with global regulatory ... Function as the molecular biology technical expert for QC labs during internal QC investigations and as the Quality...+ Must be able to function independently as the lead investigator and lead analytical investigations. +… more
- Bristol Myers Squibb (Devens, MA)
- …with requirements gathering, development, IQ/OQ/PQ, and test method validation . Apply technical knowledge, regulatory requirements, and scientific principles ... perform complex troubleshooting and problem solving. **Key Responsibilities:** + Site lead and subject matter expert for QC automation systems, supporting the… more
- Sanofi Group (Waltham, MA)
- …and change controls by working with internal AD and QC teams and CRO labs . + Monitor analytical methods performance and trend method robustness data from early to ... perform analytical methods improvement and optimization based on QC performance feedback. Lead method assessment, gap analysis, and risk assessment. + Develop and… more
- Randstad US (Marlborough, MA)
- …functionality. This role will work closely with the assay transfer technical lead . This role will mentor junior analysts and develop and facilitate training ... initiatives within the labs . The QC Scientist I Analytical will be accountable...+ Design and perform testing in support of method transfer/ validation /qualification/verification + Review/authorize data and perform analysis and interpretation… more
- Sanofi Group (Framingham, MA)
- …a continuous process platform. The function is responsible for tech transfer, process validation , dossier preparation, & PAI support to enable launch of new and LCM ... products. We are pursuing future innovations such as digital labs , factory of the future, and advanced-analytics-based process understanding and control. The… more
- Takeda Pharmaceuticals (Lexington, MA)
- …equipment and software. + Manage and provide equipment/inventory management services to all R&D labs . + Establish, lead and manage team of full-time and contract ... software/hardware upgrades for existing equipment. + Identify opportunities and lead initiatives to collaboratively improve service levels and business processes… more
- RTX Corporation (Tewksbury, MA)
- …technical objectives are met. Job duties include classified activities in secure labs and unclassified activities in a dedicated workspace. Common SWQE tasks involve ... training manuals, user guides, customer deliverables. + Systems Integration: labs , software, hardware, connectivity, tools, equipment. + Test Witnessing: test… more
- AbbVie (Waltham, MA)
- …programs in early and late stage oncology clinical development. + Lead and coordinate resources from multiple functional areas (Biomarker research, Regulatory, ... area leads. + Oversee implementation of clinical trial assays at reference labs and centralized testing vendors. Monitors all changes in study scope ensuring… more
- The MITRE Corporation (Bedford, MA)
- …will be of special interest. The CE will be expected to work across MITRE Labs to develop joint efforts with the other Innovation Centers to identify and win ... and economic growth. This is a unique opportunity to lead and shape the future of our organization and...strategies, as well as technology development, deployment, verification, and validation that drive work- product quality and impact. +… more
- Globus Medical, Inc. (Methuen, MA)
- …various software test protocols to verify design and product requirements. + Lead efforts to drive software testing of robotic, imaging and navigation systems. ... Track Pro, and Jira + Experience with documentation and validation testing for FDA regulated industries, a plus +...commitment to delivering high-quality software + Ability to attend labs /surgeries + Ability to travel up to 5% of… more