- Merck & Co. (Rahway, NJ)
- …with new equipment and infrastructure (eg Quality risk assessment, safety assessment, data integrity , change management, etc.)Provide next-level support to CSO ... Job DescriptionThe Director, Technical Operations within Global Clinical Supply (GCS) is responsible for technical leadership in support of GCS global facilities… more
- Merck & Co. (Rahway, NJ)
- …of experiments in a detailed and organized manner following ALCOA and data integrity principle.Execute test method suitability studies and implement microbiology ... rapidly growing pipeline via collaboration with stakeholders to deliver on critical data in a good manufacturing practices ( GMP ) microbiology laboratory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is required and 600, 601, and 610 is preferred.Thorough knowledge and understanding of GMP data integrity standardsKnowledge of cGMP regulations and FDA/EU ... Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are… more
- Cipla (Central Islip, NY)
- …systems etc. Maintaining regulatory compliance in accordance with cGMP and Perform Data Integrity risk assessment of current Good Manufacturing Practices (cGMP) ... only - is not for those applying for a global assignment and/or for employees working outside of Cipla's...and work with IT, QA, laboratory personnel to mitigate data integrity gaps. Partnering with other members… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …utilities, and facility qualification, process validation, shipping validation, and data integrity .Key ResponsibilitiesProvide quality and compliance oversight ... Legend Biotech is a global biotechnology company dedicated to treating, and one...process validation, equipment, utilities, and facilities qualification, shipping validation, data integrity , and maintenance activities within the… more
- Merck & Co. (Millsboro, DE)
- …Skills:Accountability, Accountability, Analytical Problem Solving, Cell Cultures, Computer Literacy, Data Entry, Equipment Maintenance, GMP Documentation, Good ... We work in the local plant linked to our global manufacturing network to ensure the highest quality of...our culture first-hand - one of strong ethics and integrity , diversified experiences, and a passion for improving animal… more
- Cipla (Fall River, MA)
- …site-critical logbooks for equipment and controlled areas. Enforce strict adherence to Data Integrity principles (ALCOA+) and GxP documentation practices during ... responsible for managing controlled documents to ensure compliance with GMP , GDP, and regulatory standards such as FDA 21...ability to multitask and prioritize tasks with strict deadlines. GLOBAL COMPANY Cipla is a leading global … more
- Cipla (Fall River, MA)
- …is responsible for the creation and revision of new and existing GMP , project handle, qualification & validation documents preparation and execution. In this ... document and SOP's procedures while ensuring their accuracy, quality, and integrity . This position reports to the Manufacturing/Packaging and partners with cross… more
- Cipla (Fall River, MA)
- …Specialist is responsible for the creation and revision of new and existing GMP batch production records as well as SOP's. In this role the Documentation ... company's document and SOP's procedures while ensuring their accuracy, quality, and integrity . This position reports to the Department Head - Manufacturing and… more
- Formation Bio (New York, NY)
- …date knowledge through internal and external partnership. Responsibilities Oversee GXP, Data Integrity , and CSV activities across various entities, investigator ... experience with oversight of CSV is preferred. Strong working knowledge of global regulatory requirements, including GMP , GCP, and ICH guidelines. Expertise… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... shared purpose-to transform the lives of patients through bold innovation, collaboration, and integrity in everything we do. We are seeking an experienced leader to… more
- Unknown (Boston, MA)
- …GMP , GLP, GCP, GPV, and CSV. This role involves the oversight of GXP, data integrity , and CSV activities across various entities, and the maintenance of ... in biotech or pharmaceutical product development. Strong working knowledge of global regulatory requirements and expertise in Quality Management Systems are… more
- Bristol Myers Squibb (Bothell, WA)
- …policies, and procedures, including operation and maintenance SOP's. + Operate and maintain GMP and non- GMP building and utility systems, including air handlers, ... files, including drawings, O&M manuals, and service records in accordance with GMP record keeping practices. **Qualifications & Experience** + Requires a High School… more
- Bristol Myers Squibb (Summit, NJ)
- …place than here at BMS with our Cell Therapy team. The Senior Manager, GMP Facilities provides leadership and direction to the 24/7 Facilities and Maintenance team ... Department. This team is responsible for ensuring that the Summit West GMP manufacturing facilities and supporting equipment are operated and maintained to ensure… more
- Bayer (Berkeley, CA)
- …analysis and determination of Quality related documentation (eg internal audits, data integrity (DI), combination product, site compliance issues, regulatory ... minds to make a real difference, there's only one choice.** **QA Compliance Specialist - GMP Processes & SQM - Berkeley, CA** **QA Compliance Specialist - GMP … more
- ThermoFisher Scientific (Middleton, WI)
- …lbs. without assistance, Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, ... This is a fully onsite role based at our GMP Laboratory in Middleton, WI. We welcome applicants from...meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission… more
- ThermoFisher Scientific (Middleton, WI)
- …Shift (Days) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Office, Some degree of PPE (Personal Protective ... _This is a fully onsite role based at our GMP Laboratory in Middleton, WI. We welcome applicants from...meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission… more
- ThermoFisher Scientific (Middleton, WI)
- …(Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail ... _This is a fully onsite role based at our GMP Laboratory in Middleton, WI. We welcome applicants from...meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission… more
- Lilly (Pleasant Prairie, WI)
- … Lead Team + Partner with global and site leadership to ensure data integrity initiatives are given appropriate priority and cross functional resources. + ... continuous improvement. Lead initiatives related to data integrity and data management for GMP...global M&Q Quality Culture as it relates to data management and integrity . Provide training, coaching,… more
- ThermoFisher Scientific (Cincinnati, OH)
- …Good Manufacturing Practices ( GMP ) Safety Standards, Office **Job Description** The QA Director, Global Data Integrity Program will own the Global DI ... on global regulations and expectations and industry trends related to data integrity . Update global policies and procedures and other program elements to… more
