- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of GMP Compliance will be a part of the Compliance Support and Remediation team within our company's Global Quality Compliance ... Health operating units and requires extensive collaboration with manufacturing sites and global GMP SMEs.-Job Function:serve as a subject matter expert for good… more
- Aequor (San Diego, CA)
- …systems o SCADA systems o analytical and process equipment computers Ensure compliance with industrial standards and GMP guidelines Apply technical solutions ... Expert Engineer - Automation/OT Hybrid San Diego site...and process equipment computers for Gene Therapy operations. Ensure compliance with industry standards and GxP guidelines. Execute project… more
- Insmed Incorporated (San Diego, CA)
- …for the QC stability and sample management operations in support of routine GMP operations at Insmed Gene Therapy. The ideal candidate will have commercial ... GMP experience in supporting stability and sample management programs.ResponsibilitiesRepresentative...and client audit readiness plans. Serve as subject matter expert for stability and sample management related topics.Establish and… more
- Merck & Co. (Rahway, NJ)
- …a new multi-modality (small molecule, biologics, vaccine) Drug Product development and GMP clinical manufacturing plant in Rahway, New Jersey. The FLEx organization ... include but not limited to:Become an MES subject matter expert and apply knowledge of manufacturing processes to partner...MES system is in a state of control and compliance .Participates in the creation and execution of the site… more
- Merck & Co. (Rahway, NJ)
- …communication. Defining and implementing operational control strategies to ensure efficient GMP processes while maintaining high-level of compliance and ... portfolio. In this role, you will work with the GMP Analytical and Raw Materials teams on strategies associated...the AR&D organization in aspects of quality control and compliance . Your main responsibilities will include: - Strategy and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety needs Product Quality: Oversees the implementation of procedures to ensure compliance with Good Manufacturing Practice ( GMP ) with respect to technical ... responsible person, the head of Patient Safety will act as the safety expert to establish and maintain processes, procedures and controls to ensure compliance… more
- Merck & Co. (Durham, NC)
- …the weekly updates of electronic departmental metrics.Responsible for ensuring compliance with government regulations through a demonstrated understanding of ... SOP's-and general knowledge of company policies/guidelines, safety/environmental regulations, and GMP 's.Attend Production Tier 1 and EN Huddle meetings and escalate… more
- Merck & Co. (Millsboro, DE)
- …ongoing talent development and organizational depthContinue building a culture of compliance with a focus of permanent inspection readinessDrive analytical and ... bottlenecksServe as key member of the site leadership teamServe as a subject matter expert for the QC lab regarding all assays and processesCollaborate with site and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Provides direct leadership to HEPA certification technicians Acts as Subject Matter Expert (SME) for HEPA certification sitewide needs Provides support to cross ... executing training as required Lead, develop, and support measurement methods in compliance with regulations (ISO 14644, EU Annex 1) Administration of HEPA testing… more
- Merck (Columbus, OH)
- **Job Description** The Director of GMP Compliance will be a part of the Compliance Support and Remediation team within our company's Global Quality ... SMEs. **Job Function:** + serve as a subject matter expert for good manufacturing practices ( GMP ) for...authority/board of health as an inspector, investigator, product reviewer, compliance officer, or other GMP /regulatory role +… more
- Kelly Services (Oklahoma City, OK)
- … GMP manufacturing processes for cell culture-based production, ensuring compliance with established protocols and regulatory guidelines. + Perform routine tasks ... + Detail-oriented and capable of maintaining accurate documentation in compliance with GMP standards. \#EX2BIO24 As part...hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical… more
- Kelly Services (Durham, NC)
- …to join our team. This critical role involves ensuring the cleanliness and compliance of cleanroom, controlled environment, and GMP laboratory settings. The ... ** GMP Technician** **Location: Durham NC** **Hourly Pay Rate:...hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are currently looking to fill a Principal GMP Data Governance Specialist position. This role plays a pivotal part in ensuring that Regeneron's Data Governance ... and practices meet the highest standards of regulatory & industry compliance . The post-holder is responsible for providing specialized knowledge and expertise… more
- Mentor Technical Group (College Station, TX)
- …technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. ... and troubleshoot issues throughout the plant. + Take on SME (Subject Matter Expert ) roles for multiple facility and equipment systems and engage in continuous… more
- ManpowerGroup (Raleigh, NC)
- …training. Strong applied and working knowledge of FDA; GMP ; GLP; compliance and NIST traceability. Expert knowledge of test equipment and capabilities ... II is expected to have a broader knowledge base of instrumentation and regulatory compliance . They will continue to train on new instrumentation areas and build an… more
- Amgen (Holly Springs, NC)
- …support of inspections. In addition, the position may entail serving as a Subject Matter Expert (SME) for GMP compliance topics in support of various aspects ... career you can be proud of. **Senior Specialist Quality Compliance ** **Live!** **What you will do** Let's do this....vital role you will be part of the Regulatory Compliance function, the Senior Specialist of Inspection Lifecycle Management… more
- Schrodinger (Cambridge, MA)
- …appropriate oversight of all vendors, including CDMOs and CROs, to ensure regulatory compliance + GMP Responsibilities: + Serve as spokesperson and technical ... looking to hire a **Director, GxP Quality Assurance and Compliance ** to join us in our mission to discover...subject matter quality expert for all matters governed by GMP -related… more
- Boehringer Ingelheim (North Brunswick, NJ)
- **Description** + Be the "go to" technical expert for Global MSAT and Operations leadership for BIAH products and processes for analysis and guidance throughout ... MO or Duluth, GA.** **Duties & Responsibilities** + Be the "go to" technical expert for Global MSAT and Operations leadership for BIAH products and processes for… more
- Astellas Pharma (Sanford, NC)
- …the AGT Supplier Management program, internal audit program, inspection management and compliance oversight required to support GMP manufacturing operations at ... The primary purpose of the Senior Manager, Quality Assurance, Compliance is to provide Quality and Compliance ...AGT GMP operations as well as GMP suppliers. This role will be responsible for maintenance… more
