- 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
- 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
- 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
- Insmed Incorporated (NJ)
- …of testing activities. Core responsibilities include maintaining regulatory compliance, ensuring data integrity , and driving operational excellence within QC ... laboratory documentation-including CoAs, test methods, protocols, and reports-meets Insmed's data integrity standards and regulatory requirements. Review and… more
