- Ultragenyx (Bedford, MA)
- …the Continued Process Verification (CPV) framework for AAV programs, including online/offline data management solutions, data integrity verification process, ... on developing data management solutions to enable monitoring the ongoing GMP production and drive process improvements for future lifecycle management. The ideal… more
- Aequor (San Diego, CA)
- …21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participate in assessmentsCollaborate with ... and regulations of computerized systems, electronic records, electronic signatures, and data integrity requirements.Collaborate with peers across Acadia on… more
- Cipla (Hauppauge, NY)
- …posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's US Subsidiaries or Affiliates. ... records, ensuring that all documentation complies with Good Manufacturing Practices ( GMP ), regulatory standards, and internal quality assurance procedures. This role… more
- Merck & Co. (Rahway, NJ)
- …Management, Clinical Trial Management, Clinical Trials, Cross-Functional Team Leadership, Data Analysis, Demand Planning, Detail-Oriented, GMP Compliance, Good ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for...business risks, & influence portfolio decisions with facts and data - Demonstrates ability to balance strategy with ability… more
- Cipla (Hauppauge, NY)
- …supporting manufacturing processes, with a particular focus on audit trail review, data integrity , and overall GxP compliance. Responsibilities: Perform detailed ... only - is not for those applying for a global assignment and/or for employees working outside of Cipla's...process, particularly in relation to audit trail management and data integrity . Ensure completion of individual training… more
- Cipla (Reid, WI)
- …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
- Merck & Co. (Rahway, NJ)
- … analytics/visualization software. Familiarity with Good Manufacturing Practices ( GMP ) requirements, quality procedures, and Standard Operating Procedure (SOP) ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for...business risks, & influence portfolio decisions with facts and data Demonstrates ability to balance strategy with ability for… 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
- 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
- Merck & Co. (Rahway, NJ)
- … Analysis, Demand Planning, Detail-Oriented, Good Manufacturing Practices ( GMP ), Interactive Voice Response (IVR), Interpersonal Relationships, Inventory Control ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for...business risks, & influence portfolio decisions with facts and data Demonstrates ability to balance strategy with ability for… more
- Ultragenyx (Bedford, MA)
- …quality mindset are in place to ensure GMP with a focus on data integrity / analysis and management Develop and maintain Key Quality Performance Indicators ... cross-functionally with Engineering, Validation, QC, Quality Systems, and MSAT functions to ensure GMP product is made in a compliant manner, with a quality mindset,… 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
- WuXi AppTec (Middletown, DE)
- …reports. - Strong knowledge of GMP regulations, ICH guidelines, and data integrity principles (ALCOA+). Preferred Qualifications - Experience in method ... method transfers, and equipment qualification, as well as maintaining compliance with GMP , corporate quality standards, and global regulatory requirements. The… more
- BeOne Medicines (Pennington, NJ)
- …cause analysis and regulatory inspections. + Digital leadership - Champion and drive Data Integrity , digital transformation and Factory of the Future initiatives ... at the site. Partner with Global Technology solutions to ensure right fit for manufacturing....Requires working in an industrial manufacturing environment including gowning, GMP , and strict regulations. + Collaborate and work closely… more
- Winland Foods (Milwaukee, WI)
- …quality audits of facility assuring company standards are maintained and product integrity is preserved. Performs record reviews. Assists with special projects. A ... with Safe Quality Food (SQF) and Good Manufacturing Practices ( GMP ). Hours: 3rd shift - 10:30pm - 7:00am Work...as directed + Provide support for sample gathering and data recording for plant trials + Perform audits to… more
- WuXi AppTec (Middletown, DE)
- …subject matter expert (SME) for analytical techniques, ensuring regulatory compliance, data integrity , and inspection readiness at all times. ... ICH regulatory requirements for drug product QC. - Maintain compliance with data integrity principles (ALCOA+), ensuring accurate and complete documentation. -… more
- Curia (Albany, NY)
- …matter expert + Provide guidance and resolution on quality issues that affect the integrity of the data or the system Inventory Management + Gather inventory ... This role will provide guidance and expertise on various global and site CSV projects to ensure that quality...all scientific applications and computer systems within Curia sites ( GMP and non- GMP ) + Inform Service Engineer… more
- GRAIL (Durham, NC)
- …sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges. GRAIL ... North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information,… more
- Repligen (Waltham, MA)
- …necessary. Ensure asset-related activities meet regulatory and internal compliance (eg, FDA, GMP , ISO) Data Analysis and Reports: Generate routine reports and/or ... OverviewMake a global impact-join Repligen.We're united by a mission to...as primary admin and SME for BMRAM to ensure integrity , user access management, and alignment with company policies.Training… more
- Winland Foods (Tolleson, AZ)
- …the process-it's who we are. Guided by our values of Excellence, Quality, Integrity , Respect, and Collaboration, our Food Quality Team Members ensure that every ... and sanitation teams, using your attention to detail and integrity to ensure compliance with food safety regulations and...in the department lead's absence. + Ensure adherence to GMP , HACCP, and safety regulations in all plant activities.… more
