- Bristol Myers Squibb (Devens, MA)
- …with cross functional teams. + Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments. Prefer to also have ... preferably with 2+ year of QA shop floor experience. Experience in FDA /EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. Project… more
- Beth Israel Lahey Health (Boston, MA)
- …of adverse events and reports them according to the guidelines of the FDA , sponsoring drug accompany (if applicable) and the IRB. May interact with sponsors ... reports for pharmaceutical company monitors as well as routine audits for the FDA , if applicable. (essential) + Monitors strict adherence to protocols by physicians,… more
- Integra LifeSciences (Braintree, MA)
- …and analyze process data. + Assist in preparing for, and participating in FDA audits, internal audits, and other regulatory agencies audits. + Demonstrate excellent ... Quality/Regulatory Compliance, or other regulated industry + Familiarity with application of FDA and/or ISO quality standards in a government regulated industry. +… more
- Integra LifeSciences (Braintree, MA)
- …or other product development studies. + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties as assigned DESIRED MINIMUM ... other cGMP regulated product preferred environment. + Familiarity with application of FDA and/or ISO quality standards in a government regulated industry. Quality… more
- Staples (Framingham, MA)
- …to safety training as required by OSHA, EPA, DOT, FMCSA and the US FDA . Works closely with Risk Management and field operations leaders to analyze incident & ... Health and Safety regulations including OSHA, DOT, FMCSA, EPA and FDA regulations specifically as they relate to warehousing and distribution operations,… more
- Integra LifeSciences (Braintree, MA)
- …of learning management software. + Experience in GMP and quality systems regulations ( FDA QSRs, ISO 13485:2016, CFR 820). + Proven experience in designing multiple ... present complex information to a variety of audiences. + Experience with FDA and/or Notified Body audits/inspections preferred. + Ability to communicate effectively… more
- Catalent Pharma Solutions (Chelsea, MA)
- …assessments and GMP evaluations of control systems to ensure they meet FDA requirements. Prepares standard operating procedures for new and existing control ... databases and process automation protocols + Preferred experience working in FDA regulated operation in the pharmaceutical/biotech field + Physical requirements:… more
- Nanobiosym, Inc. (Cambridge, MA)
- …including the creation and documentation of validation protocols that comply with FDA regulations. + Provide troubleshooting focus and direction for the team with ... in statistical analysis and statistical process control + Recent experience with an FDA regulated (21 CFR 820) and/or ISO 13485 environment PERSONAL QUALITIES + You… more
- Integra LifeSciences (Braintree, MA)
- …Process Validation, or other studies as deemed necessary. + Participate in FDA inspections, ISO Certification and surveillance audits, customer audits and internal ... + Experience with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + Knowledge of TrackWise preferred. + Knowledge of Agile product lifecycle… more
- Nanobiosym, Inc. (Cambridge, MA)
- …functional testing. + Support regulatory and quality processes with a focus on FDA and ISO 13485 compliance. Minimum Qualifications: + Master's Degree in Electrical ... + Strong understanding of compliance standards in regulated industries (eg, FDA , ISO 13485). + Proven track record of delivering production-quality PCBs-from… more