- ThermoFisher Scientific (Plainville, MA)
- …in GMP environments **Knowledge, Skills & Abilities** + Extensive knowledge of GMP regulations and global standards ( FDA , EMA, Health Canada), with the ... (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail… more
- Curia (Hopkinton, MA)
- …to meet business needs + Through a quality system approach, ensure all GMP operations are in compliance, while maintaining an efficient workflow to facilitate ... manufacturing quality oversight program is established and followed for GMP runs, including gowning into clean-rooms where necessary +...of 5 years of relevant work experience in an FDA -regulated pharmaceutical environment with at least 2 years in… more
- Cambrex High Point (Waltham, MA)
- …(Karl Fischer) and other USP compendial tests. + Strong working knowledge of GMP requirements, ICH guidelines, and regulatory expectations ( FDA , EMA). + ... review analytical protocols, reports, and SOPs in compliance with GMP and regulatory expectations. + Conduct GMP ...with GMP and regulatory expectations. + Conduct GMP testing and documentation in support of batch release,… more
- Cambrex High Point (Waltham, MA)
- …drug substances. This role will be pivotal in bridging R&D and GMP manufacturing, optimizing synthetic strategies, and ensuring robust, compliant, and efficient ... (CPPs). + Lead tech transfer of peptide processes to internal or external GMP manufacturing sites; serve as technical SME during manufacturing campaigns. + Author… more
- Integra LifeSciences (Braintree, MA)
- …MA in 2025. + Adequate knowledge of learning management software. + Experience in GMP and quality systems regulations ( FDA QSRs, ISO 13485:2016, CFR 820). + ... training plans, with subject matter experts, that adhere to GDP and GMP standards. + Identifying training needs by periodically evaluating ongoing programs to… more
- Hologic (Marlborough, MA)
- …implement, and monitor a robust Internal Audit Program, ensuring compliance with FDA regulations, ISO standards, and other global regulatory requirements. If you ... lasting impact on patient safety and innovation. **Knowledge** + Deep understanding of FDA Code of Federal Regulations (21 CFR 820), ISO standards (eg, ISO… 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 ... stability testing. + Familiarity with USP monographs and chapters, and ICH/ FDA guidance documents related to analytical method transfer and validation, impurities,… more
- Catalent Pharma Solutions (Chelsea, MA)
- …systems + Ensures that all automation designs and technical documentation adhere to GMP standards. Performs 21CFR Part11 assessments and GMP evaluations of ... control systems to ensure they meet FDA requirements + Prepares standard operating procedures for new...and process automation protocols + Preferred experience working in FDA regulated operation in the pharmaceutical/biotech field + Physical… more
- Catalent Pharma Solutions (Chelsea, MA)
- …Quality Assurance, Quality Control and batch release within a pharmaceutical GMP environment required; + Leadership experience supervising a team of ... of International Quality and Compliance standards and requirements, with preferable FDA experience; + Demonstrated knowledge of Change management and Lean… more
- ThermoFisher Scientific (Plainville, MA)
- …(Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Laboratory Setting, Office **Job Description** As part ... plan to ensure on-time approval of analytical equipment and test methods needed for GMP testing. + Build a trained, competent team of QC analysts to support … more