Bioanalytical Data Auditor Jobs

11 jobs

The individual in this role provides technical and quality support to Global Scientific Affairs (AR&D / RA / R&D) on new product development teams, on clinical supply chain projects, and on projects concentrating on systemic improvements to business and manufacturing processes. Major Duties / Responsibilities: Provides quality planning and technical support as the Quality representative or core ...

MedTox Laboratories, a LabCorp Specialty Testing Group, located in St. Paul, MN operates a SAMHSA-certified drug testing laboratory, a CAP and CLIA-certified clinical laboratory which is an FDA registered establishment. Our comprehensive laboratory and testing services coupled with our commitment to excellent customer service ensures that our Customers' testing programs operate as efficiently and ...

MedTox Laboratories, a LabCorp Specialty Testing Group, located in St. Paul, MN operates a SAMHSA-certified drug testing laboratory, a CAP and CLIA-certified clinical laboratory which is an FDA registered establishment. Our comprehensive laboratory and testing services coupled with our commitment to excellent customer service ensures that our Customers' testing programs operate as efficiently and ...

The Audit Associate Director will be responsible for independently leading the planning, conduct and reporting of routine and non-routine R&D audits of activities, data, facilities and processes to assure adherence to corporate and R&D policies, Biogen internal standards, and compliance with regulatory requirements and guidelines. The Audit Associate Director will manage Audit Manager(s) and contr...

The Audit Associate Director will be responsible for independently leading the planning, conduct and reporting of routine and non-routine R&D audits of activities, data, facilities and processes to assure adherence to corporate and R&D policies, Biogen internal standards, and compliance with regulatory requirements and guidelines. The Audit Associate Director will manage Audit Manager(s) and contr...

Since its origination in 1997, BioMarin has brought 5 products to market, with 7 more in the pipeline, over half a billion dollars of revenue and a global footprint in 40 countries. We are a recognized industry leader in rare disease development. Consistent with our origins is an entrepreneurial thread, making us a dynamic pharmaceutical company with passionate employees, creating innovative strat...

OBJECTIVES: The purpose of this position is to ensure that TDC clinical trial activities for all assigned projects are conducted in compliance with applicable regulations, Good Clinical Practice (GCP) guidelines, the International Conference on Harmonization (ICH) and Takeda Policies and Procedures. In addition, this position is responsible for ensuring that investigator sites, external vendors a...

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. Lead analytical assay, bioassay and formulation development for n...

Description: Responsible for ensuring sampling of product stability samples is performed in accordance with acceptable laboratory practice and regulatory criteria. Coordinates drug substance and finished product stability studies and samples per approved SOPs and reviews and approves test results. Leads coordination and communication between departments and across functions; coaches, mentors, lea...

Job Description Description: Responsible for ensuring sampling of product stability samples is performed in accordance with acceptable laboratory practice and regulatory criteria. Coordinates drug substance and finished product stability studies and samples per approved SOPs and reviews and approves test results. Leads coordination and communication between departments and across functions; coac...

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. Lead analytical assay, bioassay and formulation development for n...