- Charles River Laboratories (Cambridge, MA)
- …worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your ... quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.… more
- Medtronic (Billerica, MA)
- …electrical test equipment and basic troubleshooting + Experience in a regulated environment ( FDA , ISO 13485) + Ability to read and interpret schematics, BOMs, wiring ... diagrams, and test protocols + Familiarity with capital equipment, embedded systems, or PLC-based controls + Strong communication, documentation, and data interpretation skills **Shifts Available** + 1st Shift: Monday - Friday, 6:00 am - 2:30 pm + 2nd Shift:… more
- Cambrex High Point (Waltham, MA)
- …peptide APIs. + Strong understanding of regulatory guidelines (ICH Q8/Q9/Q11, FDA /EMA expectations) and process validation. + Familiarity with quality risk ... management, ICH M4/CTD, and QbD principles. + Excellent problem-solving, communication, and project leadership skills. + Understanding of quality control testing, specifications, and GMP documentation requirements. + Proficiency in analytical method… more
- Medtronic (Billerica, MA)
- …capital equipment systems. + Excellent communication skills. + Knowledge of FDA regulations and medical device quality standards. **Physical Job Requirements** The ... above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands… more
- AbbVie (Worcester, MA)
- …the qualification and validation of analytical methods in accordance with ICH, FDA , and USP guidelines, ensuring methods are suitable for late-phase development and ... regulatory submissions. + Experience using automation to standardize high-throughput workflows. + Familiarity with statistical tools for data analysis, Empower and regulatory guidelines. + Experience collaborating with the process development, quality control,… more
- Teleflex (Chelmsford, MA)
- …Process Qualification (PQ), and Test Method Validation (TMV) in accordance with ISO, FDA and corporate guidelines. * Keep track of industrial trends in applications ... and technologies, including practices and engineering tools. Maintain knowledge of technology changes to be able to implement in Teleflex operations * Support R&D activities as required utilizing technical skills to provide positive input to projects and to… more
- Eliassen Group (Boston, MA)
- …applicable. BIG PLUS: Bluetooth experience & Any industry experience that has FDA requirements OR enterprise level company experience and documentation. There will ... be lots of documentation in this role. _Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result… more
- Sanofi Group (Cambridge, MA)
- …and company activities. + Assists in ensuring product support relationships with FDA are established and maintained. + Provides input into the global organization ... for labeling strategies of marketed drugs. Demonstrates significant autonomy in carrying out assigned duties and responsibilities. **About You** **Experience:** + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful… more
- Charles River Laboratories (Worcester, MA)
- …proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal ... Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status. If you are interested in applying to… more
- Boehringer Ingelheim (Boston, MA)
- …+ Perform all Company business in accordance with all regulations (eg EEO, FDA , OSHA, PDMA, EPA, PhRMA, etc.) and Company policies and procedures. When violations ... are noted/observed they are to be immediately reported to management. Demonstrate high ethical and professional standards with all business contacts in order to main BIVF's excellent reputation within the biotech and pharmaceutical community. **Requirements**… more