- Regeneron Pharmaceuticals (Cambridge, MA)
- …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... You will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially...role, you must have at least a** BS/BA in Computer Science, Engineering, Chemistry, or Life Sciences and 5+… more
- Pfizer (Andover, MA)
- …managing and maintaining systems per site needs. + Planning and performing of Computer Systems Validation (CSV) in the regulated environment in collaboration ... GAMP 5, and Pfizer's directives and procedures. + Develop/enhance and implement Computer Systems Validation documentation such as protocols, test scripts,… more
- Tecomet (Woburn, MA)
- …improve quality systems/programs, reduce quality costs and maintain compliance within FDA and ISO regulations. This is accomplished by maintaining Tecomet principles ... Technical Files, and Design Dossiers and Change Notices. + Serve as Official FDA Correspondent. + Serve as person responsible for regulatory compliance (PRRC). +… more
- AbbVie (Worcester, MA)
- …Historian systems. + Ensure all automation systems comply with regulatory requirements ( FDA , cGMP, etc.). + Mitigates risk within functions through sound design, ... of automation systems. + Maintain documentation including functional specification, validation protocols and change controls. + Experience in change control,… more
- Charles River Laboratories (Shrewsbury, MA)
- …as appropriate. Serve as a Project Scientist for the development and validation of analytical assays. This individual would be responsible for the composition ... and execution of validation and sample analysis protocols/plan in accordance with company...required to talk, hear and work/ type at a computer . * Specific vision abilities required by this job… more
- Charles River Laboratories (Shrewsbury, MA)
- …responsibilities include serving as a Principal Investigator for the development and validation of biomarker, PK and ADA assays (eg: ligand binding assays, enzymatic ... would be responsible for the composition and execution of validation and sample analysis protocols/plan in accordance with company...required to talk, hear and work/ type at a computer . * Specific vision abilities required by this job… more
- Integra LifeSciences (Braintree, MA)
- …quality control microbiological laboratory testing of in-process, finished goods, validation studies, and adherence to all applicable regulations, policies, and ... and checklists. + Assist as needed in test method validation , investigation studies or other product development studies. +...studies. + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties… more
- Integra LifeSciences (Boston, MA)
- …quality control Analytical laboratory testing of in-process, finished goods, validation studies, and adherence to all applicable regulations, policies, and ... as needed. + Assist as needed in test method validation , investigation studies or other product development studies. +...(CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties… more
- Fresenius Medical Center (Lawrence, MA)
- …and Regulations such as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning and implementation of risk ... individuals with disabilities to perform the essential functions. . Extended computer -based work in an office environment. **EDUCATION** . Bachelor's Degree required… more
- Integra LifeSciences (Braintree, MA)
- …archived materials and solutions. + Assist as needed in test method validation , implementation, and execution. + Provides database support, generate reports and ... analyze process data. + Assist in preparing for, and participating in FDA audits, internal audits, and other regulatory agencies audits. + Demonstrate excellent… more