- Bristol Myers Squibb (Devens, MA)
- …partner with Manufacturing, Quality Control, or Supply Chain to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. ... approved procedures + Review manufacturing or testing records to ensure compliance with approved procedures. Communicate and resolve discrepancies and escalate as… more
- Sumitomo Pharma (Boston, MA)
- …cross-functional ad-hoc projects or assignments that require safety input, ensures compliance with regulations/internal SOPs, and fosters a culture of "Safety First" ... and risk management regulations and guidelines, including pre- and post-marketing US FDA and/or EU ICH safety requirements** + Expertise in medical review of… more
- Catalent Pharma Solutions (Chelsea, MA)
- …is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer, and Catalent employee.** **The ... laboratory equipment, and staff training + Responsible for GMP compliance as related to the laboratories, equipment, and staff....regulatory audits preferred, but ability to apply applicable regulations ( FDA , EU, Japan, USP, ICH, etc.) in a phase… 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… more
- Sumitomo Pharma (Cambridge, MA)
- …Summary of Efficacy (ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional ... Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency… more
- Integra LifeSciences (Braintree, MA)
- …+ Ensure compliance with safety, environmental, and regulatory standards (eg, FDA , ISO). + Maintain accurate records of refrigerant usage and system performance. ... regulated industries and a strong understanding of refrigeration systems, compliance standards, and preventive maintenance practices. **Key Responsibilities:** +… more
- Zimmer Biomet (Braintree, MA)
- …recognised. **What You Can Expect** Maintain Site Quality programs to ensure compliance to domestic and international medical device regulations. **How You'll Create ... and lead audits, both internal and external, to demonstrate compliance with GMP, ISO, CMDR, and MDD regulations. +...working knowledge of current USA Food and Drug Administration ( FDA ) and global laws, regulations and standards. + Familiarity… more
- Integra LifeSciences (Mansfield, MA)
- …cover sterilization programs across sites. + Obtains and maintains knowledge of FDA , ISO, and EN sterilization and related microbiology standards and guidelines, for ... 11137, ISO 11135 and environmental monitoring requirements. + Supports EU MDR compliance by performing gap analysis and formulating gap resolution plans + Subject… more
- Charles River Laboratories (Shrewsbury, MA)
- …interpretation, and reporting of study data and assuring the regulatory compliance of these projects, as appropriate. Additional responsibilities include serving as ... in the direction and execution of assigned studies in compliance with regulations as they apply to the conduct...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- Takeda Pharmaceuticals (Boston, MA)
- …analysis plans, CRFs, study reports) and processes. + Strategic knowledge of FDA and ICH regulations and industry standards and quality control principles. + ... standards and pipelines for multiple third-party vendors, ensuring data integrity, compliance , and alignment with regulatory and business requirements. + Strong… more