- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Investigator Compliance Specialist as part of the Technical Operations team based ... that would provide reduction in COGs, increase throughput, capacity and quality compliance .Provide technical expertise in automation projects from user… more
- Aequor (Irvine, CA)
- …teams ( Quality , Manufacturing, R&D, Supply Chain, Finance, etc.). Ensure compliance with the company's Quality System policies and procedures and ... are implemented to address the root cause of trending issues. Supports quality functions pertaining to manufacturing line support and maintenance, including SAP.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a QA Shop Floor Specialist as part of the Quality Operations team based in Raritan, New ... Jersey. Role OverviewThe QA Shop Floor Specialist is an exempt level position responsible for the...controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance… more
- Merck & Co. (Durham, NC)
- …Engineering Standards, Good Manufacturing Practices (GMP), Manufacturing Process Validation, Regulatory Compliance , Root Cause Analysis (RCA), Strategic ... build and maintain strong and trusting relationships with site technical operations, quality , regulatory , stability, and other stakeholders to ensure effective… more
- Merck & Co. (Rahway, NJ)
- …Enabling Technologies Department in Rahway, New Jersey is seeking a Senior Specialist to enhance our expertise and expand our capabilities in high-throughput ... of biocatalysis and protein engineering on human health. The Senior Specialist designs, executes, and oversees high-throughput experimentation and automation efforts… more
- Aequor (Golden Valley, MN)
- …This position is based in the US within the North America Labeling and Regulatory Compliance team but partners globally to support business needs. Key ... Job Description: The Certifications Specialist is responsible for assuring compliance ...Labeling or related field 1-3&plus years of experience in regulatory , quality and/or product commercialization Basic understanding… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Validation Specialist I as part of the Quality team based in Raritan, NJ. ... Role OverviewThe QA Validation Specialist role is an exempt level position with responsibilities...process validation, shipping validation, and data integrity.Key Responsibilities Provide quality and compliance oversight for computer systems… more
- Merck & Co. (Rahway, NJ)
- …guidance of dCMC Regulatory A uthoring L eadership , t he Senior Specialist , Regulatory Authoring Data Analyst, will o ptimize regulatory authoring ... supply. - A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a… more
- Aequor (Thousand Oaks, CA)
- …lifecycle management of R&D controlled documents to ensure compliance with regulatory standards and internal quality procedures. This role emphasizes ... quality control, template adherence, and milestone tracking. The lead works closely with stakeholders to coordinate document workflows, perform rigorous QC reviews, and ensure timely and accurate completion of documentation deliverables within the… more
- Merck & Co. (Rahway, NJ)
- …and validation of process and analytical data to ensure consistency and quality before auto generation into regulatory documentation. Collaborate with source ... and supply.A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- ** Quality Assurance & Regulatory Affairs Compliance Specialist ** **Position Summary** Catalent, Inc. is a leading global contract development and ... development and manufacturing challenges. The ** Quality Assurance & Regulatory Affairs Compliance Specialist ** is responsible for quality and… more
- Commonwealth Care Alliance (Boston, MA)
- …Summary: Reporting to the Director, Claims Operations & Quality Assurance, the Regulatory Compliance & Audits Sr. Specialist II is responsible for ... This role is housed within the Claims Operations & Quality Assurance team and works closely with Cognizant (TPA)...does not have direct reports. Essential Duties & Responsibilities: Regulatory Compliance & Monitoring * Monitor CMS… more
- ThermoFisher Scientific (Greenville, NC)
- …plays a vital role in maintaining our operations' quality and regulatory compliance standards. As a Deviation Specialist , you will play a crucial role in ... + Recognize and detail departures from standard operating procedures (SOPs), quality standards, or regulatory guidelines. + Perform detailed investigations… more
- Danaher Corporation (Richmond, IL)
- …which makes everything possible. The Principal Specialist , Quality Assurance and Regulatory Compliance Service ... role will provide Quality & Regulatory support and leadership to maintain, improve, and support...and the Leica Biosystems Business Units (BUs), to ensure compliance . This position will also lead the quality… more
- J&J Family of Companies (Danvers, MA)
- …America **Job Description:** We are searching for the best talent for a **Principal Regulatory Compliance Specialist ** to be located in Danvers, MA. Fueled ... more at https://www.jnj.com/medtech. **Purpose:** The position of the Principal Regulatory Compliance Specialist is responsible...member of the Abiomed and J&J Regulatory Compliance teams, will work with Quality Operations… more
- Houston Methodist (Houston, TX)
- At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for leading, coordinating and performing study specific ... Operating Procedures (SOPs), and study specific protocols/plans and processes. The Sr Regulatory Compliance Specialist position maintains documentation for… more
- Fujifilm (Santa Ana, CA)
- **Position Overview** The EHS Regulatory & Product Compliance Specialist plays a critical role in ensuring the safety, compliance , and market access of ... compliance activities, with specific focus on hazard communication and chemical regulatory compliance . The specialist will assist in converting… more
- Houston Methodist (Houston, TX)
- At Houston Methodist, the Regulatory Compliance Specialist position is responsible for coordinating and performing study specific regulatory processes ... Procedures (SOPs), and study specific protocols/plans and processes. The Regulatory Compliance Specialist position maintains... and/or important safety related issues. + Perform high quality clinical review of regulatory forms and… more
- Danaher Corporation (Richmond, IL)
- …Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Specialist , Regulatory Compliance for ... regulatory affairs skills. This position reports to the Director, Quality Assurance and Regulatory Compliance (Management Representative) and is part of… more
- Abbott (Maple Grove, MN)
- …the function of a RA QA Specialist is to combine the knowledge of Regulatory , Quality and Compliance to lead and assist implementation projects for ... **The Opportunity** We are looking for our next **Senior Regulatory Quality Specialist ** to join...emerging regulations and supporting quality compliance related activities for the GRS… more
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