- Catalent Pharma Solutions (Chelsea, MA)
- …Previous participation in regulatory audits preferred, but ability to apply applicable regulations ( FDA , EU, Japan, USP, ICH, etc.) in a phase appropriate manner is ... required + Thorough knowledge of chromatography (HPLC, GC), FTIR and various other analytical techniques required + Experience with statistical data analysis, DOE, HPLC software systems, trending analysis preferred (Empower, JMP, etc.) + Experience with the… more
- Merck (Boston, MA)
- …management, communication, and networking skills + A thorough comprehension of FDA , OIG, HIPAA, and other ethical guidelines, laws, and regulations relevant ... to the pharmaceutical industry and its customers + Ability to organize, prioritize, and work effectively in a constantly changing environment + Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel, Teams, OneNote) + Familiarity with… more
- Medtronic (Boston, MA)
- …Prochain and Resource First + Experience working under regulations of the FDA , notified bodies, and other regulatory agencies for successful commercial launches + ... Product launch experience working with Global teams _\#SurgicalPMO_NowHiring_ **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… more
- Mentor Technical Group (Boston, MA)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six… more
- North Coast Seafoods (Boston, MA)
- …the following motions: bending, twisting, squatting and reaching . Exposure to FDA approved cleaning chemicals . Exposure to temperatures: <32 degrees Fahrenheit . ... Ability to work in wet and dry conditions . Ability to work Monday-Friday, weekends when needed . Ability to use tools and equipment, including knives or box cutters, pallet jacks, fork-lifts North Coast Seafoods is an equal opportunity employer and does not… more
- Bristol Myers Squibb (Devens, MA)
- …requirements. **Knowledge and Skills:** + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred. ... + Driven and motivated individual to learn and execute Cell Therapy Manufacturing operations + Must have the ability to work assigned shift (Day, Night, Weekends and/or Holidays). + Must be able to work in a cleanroom environment and perform aseptic processing… more
- Actalent (Billerica, MA)
- …standards regulations technical procedures journals regulatory publications. Familiarity with FDA regulations. Working knowledge of MS Word Excel PowerPoint MS ... Outlook Project Expertise in cGMPrsquos and quality systems as related to terminally sterilized medical devices. Knowledge in compendial AAMI USP ISO methodologies and techniques including: ISO 13485 11135 14644 series 14698 series 17665 17664 11737-1/-2/-3… more
- Rise Baking Company (Worcester, MA)
- …building in a manner that meets and complies with all food safety policies, FDA and OSHA regulations. Essential Functions * Perform basic wash area duties including ... running a pan washer, cleaning utensils by hand when needed, etc. * Perform basic machine disassembly/setup for cleaning (eg, covers, piping, cover electrical with plastic) * Complete cleaning tasks per SSOPs * Recognize and address equipment needing deep… more
- Bristol Myers Squibb (Devens, MA)
- …cryogenic storage (LN2) is preferred + Experience with health authorities (ie, FDA ) for audit support + Experience and familiarity with electronic systems including ... SAP, and manufacturing execution systems (MES) including Syncade and DeltaV + Safety and Quality mindset; proven ability to build a culture around these values and to communicate critical information clearly and in a timely manner to team and to manager as… more
- Aerotek (Chicopee, MA)
- …adherence to strict health and safety regulations as per organizations like the FDA , ISO, and DEP. The role involves hands-on work with advanced machinery and ... equipment in a controlled environment. **Job Type & Location** This is a Contract position based out of Chicopee, Massachusetts. **Pay and Benefits** The pay range for this position is $30.00 - $40.00/hr. Eligibility requirements apply to some benefits and may… more