- Merck & Co. (Durham, NC)
- …bulk active ingredient, finished product, and laboratory testing for the BCG vaccine.The Specialist , Quality Control participates in a team of analysts in the ... in equipment validation, process validation, and GMP laboratory readiness.- The Quality Operations Laboratory Specialist performs laboratory testing on a… more
- 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 ... including Safety Data Sheets (SDS), SOP, and work instructions Familiarity with Quality Management Systems and electronic document control systems … 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
- Merck & Co. (Rahway, NJ)
- …such as master inventory lists, qualification documentation, calibration documentation, computer system inventories Support internal and external quality audits ... change management and deviation management.Experience supporting internal and external quality audits.Experience in instrument computer system validationTag:… more
- Eisai, Inc (Raleigh, NC)
- …with applicable regulatory requirements (eg, FDA, EMA, ICH) and quality systems .Strong oral and written communication skills.Strong attention to detail ... you. The QA Specialist plays a critical role in ensuring the quality and compliance of commercial and clinical products manufactured at the Eisai Raleigh… more
- Aequor (Thousand Oaks, CA)
- …Drug Product Formulation and Vial/Syringe Filling operations Experience with various quality systems including change control, deviations, corrective and ... to peers and senior leadership team. Additional Responsibilities include: Engaging with Quality and Regulatory teams to ensure alignment and compliance across… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …actions.Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements.Drive continuous improvementOther duties may ... 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.… 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 ... and senior leaders.- - Works directly in the SAP system to establish a consolidated , visible forecast for...relationship management. - Technical Proficiency: familiarity with supply chain systems and software ( eg SAP or Oracle) and… 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...manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and… more
- Merck & Co. (Rahway, NJ)
- …Standard Operating Procedures (SOP) and current GXP documents.Experience with quality systems .Excellent organizational skills.Desire and willingness to learn, ... Rahway, New Jersey.The Sterile Process Engineer role at the Senior Specialist level will leverage the individual's leadership, technical, and communication skillsets… more
- Abbott (Maple Grove, MN)
- …with diabetes from routine fingersticks. The Opportunity We are looking for our next Senior Regulatory Quality Specialist to join our team on-site out of our ... Maple Grove, or St. Paul, MN locations. This Regulatory Quality Senior Specialist position...the GRS department. With limited supervision, coordinates and compiles regulatory procedures/processes and leads Regulatory systems… 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 ... make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant… 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
- Twist BioScience (South San Francisco, CA)
- …sessions, as needed.Each Twist employee is responsible for complying with applicable Quality Management System (QMS)/Information Security Management System ... The Scientific Technical Support Specialist will be responsible for providing best in...their daily activities and ensuring product or service meets regulatory requirements, customer requirements and the established QMS/ISMS policies… more
- Boston Scientific (Maple Grove, MN)
- …with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations Solid understanding and ... exposing patients to less risk and pain. This role provides opportunity to gain regulatory experience in US, China, Japan, and other international regions. This is a… more
- BioTalent (Carlsbad, CA)
- …and design changes. Review and assess regulatory impact of design and quality system changes (ECOs, MCOs, NCMRs, SDRs). Drive process improvements and ensure ... in beautiful North San Diego! We're seeking an experienced Senior Regulatory Affairs Specialist to support global regulatory submissions and compliance… more
- Conmed (Denver, CO)
- …classification and regulatory strategies. Train others in the use of regulatory systems and tools. Raise issues, roadblocks, and grievances through ... Job Summary: The Sr. Regulatory Affairs Specialist plays a critical...to other RA Staff and project team. Collaborate with quality , clinical, legal, commercial, and reimbursement teams to align… more
- Marmon Holdings, Inc. (Addison, TX)
- …fostering a culture where everyone's empowered to be their best. Job Scope The Regulatory Affairs (RA) Specialist is responsible for ensuring regulatory ... accordance with applicable regulatory requirements (FDA, ISO, CE, etc.). The Regulatory Affairs Specialist will assist in regulatory submissions,… more
- Enigma Search (Alameda, CA)
- About the job Snr. Supplier Quality Specialist (Contract) Are you a seasoned Quality Assurance professional with a passion for ensuring the highest standards ... Specialist , you'll be at the forefront of ensuring quality throughout the supply chain. Your responsibilities will include:...(eg, ASQ, CQA) is strongly preferred. Strong knowledge of quality systems , risk management, and supplier audit… more
- Boston Scientific (Marlborough, MA)
- …and procedures Foster a work environment of continuous improvement that supports BSC's Quality Policy, Quality System and the appropriate regulations for ... 50 percent of all urology surgical procedures. This role is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for… more
