- Cambrex High Point (Waltham, MA)
- …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… more
- Hologic (Marlborough, MA)
- …13485:2016, ISO 14971), MDSAP, and other global regulatory requirements. + Expertise in Quality Systems and GMP compliance in regulated industries such as ... monitor a robust Internal Audit Program, ensuring compliance with FDA regulations, ISO standards, and other global regulatory requirements....training. + Minimum of 10 years of experience in Quality Systems and GMP within medical devices,… more
- Zimmer Biomet (Braintree, MA)
- …respected, empowered and recognised. **What You Can Expect** Maintain Site Quality programs to ensure compliance to domestic and international medical device ... and implement processes, procedures and instruction to sustain and improve the Quality Management System. + Support Top Management in the development and… more
- Amgen (Cambridge, MA)
- …development, method validation, method transfer, process and product development support, and GMP testing of late phase drug substances and drug products. The ... technical aspects of developing the analytical tools to gain understanding of key quality attributes in product and process for late phase synthetic programs. The… more
- System One (Devens, MA)
- …Leadership experience with in a GMP environment + Strong working knowledge of GMP , FDA , and DEA regulations + Excellent communication skills and the ability ... and equipment to meet production targets while maintaining product quality and safety. + Maintain full compliance with SOPs,... and safety. + Maintain full compliance with SOPs, FDA cGMPs, DEA regulations, and other applicable federal, state,… more
- System One (Devens, MA)
- …or related technical field (entry-level to 2+ years' experience) + Strong understanding of GMP and FDA regulatory requirements + High level of safety awareness ... of Active Pharmaceutical Ingredients (API) and require strong knowledge of GMP practices and hands-on manufacturing experience in a controlled, aseptic environment.… more
- ThermoFisher Scientific (Plainville, MA)
- … testing. + Build a trained, competent team of QC analysts to support GMP testing. + Coordinate daily Quality Control activities for Molecular, Viral, Cell, ... (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Laboratory Setting, Office **Job Description** As part… more
- Catalent Pharma Solutions (Chelsea, MA)
- …needs.** **Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent ... all automation designs and technical documentation adhere to Good Manufacturing Practices ( GMP ) standards + Performs 21CFR Part11 assessments and GMP evaluations… more
- Abbott (Westford, MA)
- …train and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA , GMP , and all other applicable agency regulations. + Ensure a ... meet new product introduction schedules, and enhance productivity and product quality . **MAIN RESPONSIBILITIES** + Provide leadership to engineering and facilities… more
- North Coast Seafoods (Boston, MA)
- …work. + Safety & Compliance: Enforce safety regulations and compliance with OSHA, FDA , USDA, and GMP standards in a seafood manufacturing environment. + ... of Good Manufacturing Practices and food safety regulations + Understand OSHA/ FDA /USDA requirements in a seafood manufacturing environment + Intermediate computer… more