- AUROBINDO (Durham, NC)
- …comply with relevant rules and regulations, such as current USP-NF, cGMP , safety protocols, in-house SOPs, and testing procedures.QUA ResponsibilitiesLeading a ... department's day-to-day operations.Responsible for Data Integrity compliance and laboratory GLP/ cGMP /GxP complianceEnsuring the accuracy of analytical measurements and compliance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …therapy products in accordancewith Janssen policies, standards, procedures, and Global cGMP .Work with QC organization to support the successful transfer of QC ... Lab functions to the Raritan cGMP facility to test products.Review and approval of standard...manner consistent with the safety policies, quality systems and cGMP requirements.Critically support investigations and reports, interpret results, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual ... therapy production through safe and compliant manufacturing operations according to cGMP requirements. This role will require CQV and engineering experience, ability… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team based on an ... a manner consistent with safety policies, quality systems, and cGMP requirements.Build strong partnerships with Manufacturing, Warehouse, Engineering, and Quality,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on a modified second shift. ... therapy production through safe and compliant manufacturing operations according to cGMP requirements. This individual will support the organization in its build… more
- Aequor (Swiftwater, MN)
- …Develop and execution of training programs for appropriate audiences Comply with cGMP and other internal and external quality and regulatory guidance and health ... procedures and related technical documents to align to program strategies under a cGMP environment. Work closely with other members of the department to share… more
- Novo Nordisk Inc. (Boulder, CO)
- …the authoring and review of technical reports and protocols in support of cGMP activities. Serve as the technical expert supporting the development of process ... manufacturing Collaborate with cross functional teams for external or internal cGMP manufacturing of drug substance API. Communicate Novo Nordisk manufacturing… more
- Merck & Co. (Durham, NC)
- …value to the achievement of team goalsUnderstand and apply cGMP /GLP, Compendial, and other applicable regulatory requirements toward analytical testingCapability ... Specialist, Quality Control will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product… more
- Merck & Co. (Durham, NC)
- …Minimum 8 years of progressive Maintenance Engineering and Leadership experience in cGMP Maintenance/Engineering Discipline (6 Years with a master's degree or MBA: 3 ... time management skillsWorking knowledge regulatory requirements in accordance with cGMP manufacturing operations and demonstrated experience of interacting with… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …industry preferred.Familiarity with pharmaceutical manufacturing processes and cGMP practices preferred.PMP or PRINCE2 certification preferred.An appropriate ... mix of education and experience in a cGMP manufacturing environment may be considered in lieu of...manufacturing environment may be considered in lieu of a formal degree.Experience with pharmaceutical manufacturing processes and cGMP practices… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with the establishment of appropriate controls and traceability according to cGMP requirements.Support and manage change controls, draft and review SOPs and ... principles, concepts, practices, standards, validation, and qualification within a cGMP manufacturing environment.Maintains accurate working knowledge of governmental/regulatory requirements… more
- AUROBINDO (Durham, NC)
- …oversight and final review of investigations to ensure adherence to cGMP , rigorous technical content, investigation clarity and completeness Qualifications - Skills ... industryFamiliarity with Empower 3 data collection systemWorking knowledge of cGMP 's and regulatory requirements as they apply to pharmaceutical testing.… more
- Merck & Co. (Durham, NC)
- …members to develop reliable, consistent manufacturing processes that meet cGMP requirements.Support safety programs (LOTO, HECP, etc.) and environmental compliance ... maintenance databasesProject management experience including change control and equipment qualification.Preferred: cGMP experience in a sterile, bulk or finished pharmaceutical… more
- Aequor (Vacaville, CA)
- …Associate is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Level I associates are expected to execute process recipes, follow ... and equipment. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …required. Advanced degree preferred.2-3 years of operations experience within a cGMP environment in the biotech/biopharma industry and Cell/Gene Therapy cGMP ... manufacturing experience preferred.Provide support and technical expertise to the Manufacturing team in support of ongoing manufacturing operations.Ability to accommodate changes in the schedule including working on shift as necessary to support operational… more
- Merck & Co. (Durham, NC)
- …members to develop reliable, consistent manufacturing processes that meet cGMP requirements.Education Minimum Requirement: High School Diploma/GED or higherRequired ... BioWorks Certificate)Experience training others through hands-on trainingExperience with on-the-floor cGMP manufacturing and familiarity with regulatory requirementsDemonstrated ability to… more
- Merck & Co. (Durham, NC)
- …team members to develop reliable, consistent manufacturing processes that meet cGMP requirements. Education Minimum Requirement: High School Diploma/GED or higher ... Experience training others through hands-on training Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements Demonstrated ability… more
- Twist BioScience (South San Francisco, CA)
- …and providing quality assurance sign-off.Stay up-to-date on the latest cGMP regulations and quality engineering practices.Provide quality support to quality ... or biotech manufacturing and a thorough knowledge and understanding of cGMP .Experience in Pharmaceutical, NGS, and/or Molecular Diagnostics a plus.Highly organized,… more
- Aequor (Swiftwater, MN)
- …laboratory while strictly adhering to site work instructions, Federal Regulations, cGMP , and Pasteur policies and procedures. This position requires the individual ... to detail and strong writing skills are crucial. The individual must be familiar with cGMP guidelines. The candidate must be able to work in a team environment. As a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Advanced degree preferred.A minimum of 10 years of operations experience within a cGMP environment in the biotech/biopharma industry with a minimum of 5 years of ... people leader experience. Cell/Gene Therapy cGMP manufacturing experience preferred.An ability to build strong partnerships and effectively integrate with external… more
Related Job Searches:
Analyst Quality Control cGMP,
GMP cGMP Sterile Aseptic,
Manager Analytical Chemistry cGMP,
Manager Quality Validation cGMP,
Senior cGMP Lab Technician,
cGMP Associate Director Process,
cGMP Audits Manager,
cGMP Process Development Specialist,
cGMP Quality Control Lab,
cGMP Quality Manager Analytical