- Bristol Myers Squibb (Devens, MA)
- …+ Ability to research, understand, interpret and apply internal policies and regulatory guidelines + Proficient computer skills with knowledge of several digital ... with 4+ year of [insert validation discipline] experience. Experience in FDA /EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. +… more
- Bristol Myers Squibb (Devens, MA)
- …+ Ability to research, understand, interpret, and apply internal policies and regulatory guidelines + Proficient computer skills with knowledge of several digital ... environment with limited information and/or time-constraints. + Experience in FDA /EMA regulations in biopharmaceuticals or cell therapy manufacturing is required.… more
- Medtronic (Boston, MA)
- …adhere to company policies and procedures + Adheres to financial, regulatory , quality compliance standards and requirements. **Influence and Selling:** + Identify, ... in a manner that adheres to ethics & compliance guidelines and FDA requirements **Communication:** + Work with internal functions (marketing, customer service,… more
- Charles River Laboratories (Shrewsbury, MA)
- …with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling ... proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal… more
- J&J Family of Companies (Raynham, MA)
- …the implementation and management of calibration activities to ensure compliance to applicable FDA regulations (ie 21 CFR Part 820.72) guidance documents and ISO as ... adequacy and consistency of calibration activities and documentation in terms of regulatory compliance and technical soundness. + Coordination or ownership of all… more
- ThermoFisher Scientific (Agawam, MA)
- …matrix. + Ensures policies and procedures are followed maintaining compliance with regulatory and operational procedures. + Reviews all internal reports to measure ... are met. + Ensures storage of materials is in keeping with State and Federal FDA , Board of Pharmacy, DEA, ATF, EPA and OSHA regulations. + Delivers with decision… more
- United Therapeutics (Boston, MA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... + Conduct field rides within field regions with direct reports to evaluate regulatory compliance and abilities to deliver 'best in class' training and education +… more
- Charles River Laboratories (Shrewsbury, MA)
- …+ Other: Demonstrated analytical and problem solving capabilities. Understanding of regulatory requirements of study types assigned, as well as Testing Facility ... proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal… more
- Dana-Farber Cancer Institute (Methuen, MA)
- …performed by other employees. + Ability to maintain compliance with all regulatory agency (eg Joint Commission (formerly JCAHO),CAP, FDA , AABB) requirements. ... + Manual/visual dexterity necessary to prepare specimens, prepare solutions, screen specimens and operate a computer software system. + Ability to perform venipuncture techniques. At Dana-Farber Cancer Institute, we work every day to create an innovative,… more
- Dana-Farber Cancer Institute (Boston, MA)
- …samples are tested in the same manner as patient specimens. + Follow regulations ( FDA , CLIA, HIPAA, OSHA, state), standards (FACT, JC) and safety guidelines. + If ... applicable safety equipment. + If needed, participate in government or regulatory agency inspections. Minimum Education requirement: + Associate degree in chemical,… more