- Twist BioScience (South San Francisco, CA)
- The Regulatory Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on ... labeling, and SOP's. This role is crucial in supporting global product compliance , ensuring that all documentation accurately reflects regulatory requirements… more
- Eisai, Inc (Raleigh, NC)
- …from you. The QA Specialist plays a critical role in ensuring the quality and compliance of commercial and clinical products manufactured at the Eisai ... Raleigh facility. This position is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating with internal… more
- Merck & Co. (Rahway, NJ)
- …Metrology, Metrology Equipment, Personal Initiative, Pharmaceutical Management, Pharmacy Regulation, Quality Auditing, Regulatory Compliance , Reviewing ... Job DescriptionTitle: Specialist , Metrology and Validation, Analytical Research & DevelopmentJob Description-The Analytical Research & Development (AR&D) External… more
- Aequor (Thousand Oaks, CA)
- …senior leadership team. Additional Responsibilities include: Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network ... of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting… more
- Merck & Co. (Boston, MA)
- …accelerating research and innovation.- We are seeking a passionate and knowledgeable Senior Specialist to join our Library team.- In this position, you will be ... linking our stakeholders with scientific and medical information resources. A successful Senior Specialist will have a drive for mastering a wide range of databases… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Validation Specialist III 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)
- …Rahway, New Jersey.The Sterile Process Engineer role at the Senior Specialist level will leverage the individual's leadership, technical, and communication skillsets ... selected candidate will lead and contribute to the launch and regulatory certification of the facility, concluding startup and operational readiness activities.Once… more
- Aequor (Hicksville, OH)
- …employees. Adheres to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, ... Packager - Support Specialist 2nd shift Packaging = /hr pay rate...is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory … more
- Merck & Co. (South San Francisco, CA)
- …AI (GenAI) to enhance document authoring processes, thereby improving efficiency and compliance in regulatory submissions.The candidate will play a key role ... developing, implementing, and optimizing GenAI approaches to streamline the creation and quality control (QC) of regulatory submission documents. The candidate… more
- Merck & Co. (Rahway, NJ)
- …supplies . - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (Durham, NC)
- …DescriptionJoin our dynamic Engineering, Maintenance, & Utility Department as a Senior Specialist , where you will play a crucial role in enhancing asset reliability ... leadership skills to empower teams, solve complex technical challenges, and ensure compliance with industry standards while making a tangible impact on our… more
- Merck & Co. (Durham, NC)
- …Process Troubleshooting, Production Operations, Production Support, Project Management, Regulatory Compliance , Teamwork, Training and Development-Preferred ... substance and drug product, including product inspection, warehouse, utilities, and quality control laboratories.The Specialist , Operations will be responsible… more
- Merck & Co. (Durham, NC)
- …manufacturer? If so, then this is the opportunity for you!The Associate Specialist , Calibration is a member of the Engineering, Maintenance and Site Services ... sites.- This includes Energy Center, Vaccine Bulk and Manufacturing Facilities, Quality Labs, Material Management Storage Facility (MMSF) and projects. At times,… 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
- 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
- Boar's Head Brand/Frank Brunckhorst Co., LLC (Sarasota, FL)
- Hiring Company: Delicatessen Services Co., LLC Overview:The Regulatory Compliance Specialist is responsible for maintaining and managing regulatory ... document requests and associated regulatory requirements. The Regulatory Compliance Specialist is responsible...requests as needed to support labeling claims or new regulatory requirements. + Uses the Quality Management… more
- Stryker (Sacramento, CA)
- …recommend comprehensive upgrades to prevent future issues. We are currently seeking a Regulatory Compliance Specialist to join our **Endoscopy** **Division** ... CO or remote. **What you will do** As the Regulatory Compliance Specialist , you will...a regulated manufacturing environment is required; preferably in a Regulatory or Quality role. + Knowledgeable in… more
- Caterpillar, Inc. (Peoria, IL)
- …world, so we can all enjoy living in it. The key role of an Engineering Specialist - Technical Regulatory Compliance is that of principal contributor on a ... technology, costs, sales, and customer perceptions. Success factors for the Engineering Specialist - Technical Regulatory Compliance are strong… 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
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