- Novo Nordisk Inc. (Boulder, CO)
- …cost & timely completion of all validation deliverables. Relationships Associate Director. Essential Functions Perform, review & approve validation ... & communicate effectively across multiple departments to schedule & perform validation /revalidation assignments Review & approve documents in accordance with… more
- Novo Nordisk Inc. (Durham, NC)
- …and help us make what matters. The Position Plan, manage & perform laboratory validation activities. Routine review of laboratory validation procedures & ... all deliverables. Relationships Manager. Essential Functions Ensure accuracy & compliance of validation & equipment records Responsible for validation of QC… more
- Eisai, Inc (Nutley, NJ)
- …to hear from you.JOB SUMMARY:As a member of the Data Analytics group, the Associate Director, Commercial Analytics is part of a high performing team that provides ... identify solutions to field needs with existing report data. Lead the review of recommended solutions with field leadership for confirmation and development of… more
- Catalent (San Diego, CA)
- …production of samples and approve the respective specification of raw materials. Review calibration, validation and preventative maintenance certificates of ... Job Title: Quality Assurance Associate , Analytical City: San Diego State : CA..., Analytical City: San Diego State : CA JOB DESCRIPTION: Review of analytical release and stability data, involving … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …established standard processes to facilitate alignment of technology transfer and validation activities across the projects for (mAb, Drug Substance, Drug Product, ... the main interface to internal and external manufacturing sites. Review technical documentation (protocols, reports) associated with manufacturing, technology… more
- Aequor (Seattle, WA)
- …working cross-functionally Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the ... including the document approvals, document change control process, periodic review and system reporting. Duties/Responsibilities: Primary responsibilities include: Managing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRF review , SAP development, analysis files development, statistical analysis accuracy validation , results interpretation and CSR input and review . Acts as ... complex study problems.Responsibilities- Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation,… more
- Nesco Resource (West Jefferson, OH)
- …blood and tissue processingPrepare reagents. o Contribute to the development and validation of equipment and biological assays. o Understand and perform dilutions ... manner and adhere to these procedures. o Perform timely quality control and/or technical review of electronic and/or paper data. o Create and maintain study files in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRF review , SAP development, analysis files development, statistical analysis accuracy validation , results interpretation and CSR input and review . Acts as ... study problems. Responsibilities Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation,… more
- FUJIFILM Holdings America Corporation (College Station, TX)
- …representing a source of pride for the area.The Senior Computerized Systems Validation Engineer, under general direction, will be responsible for oversight of all ... system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements. This… more
- Merck & Co. (Durham, NC)
- …and other project objectives.Provide technical guidance/support including authoring or review and approval of system commissioning and qualification documents, ... processesProviding direct support for regulatory inspections and audits and other validation activities by serving as the subject matter expertUnderstands and… more
- Merck & Co. (Durham, NC)
- …and maintenance of equipment/utility systems.Assist with execution of calibration, automation, validation and additional testing, as requiredWork within a team to ... safety, GMP, and calibration/maintenance procedures.Facilitates contractors by obtaining bids, review contracts, supervises work execution, and follows-up on contract… more
- HITT Contracting (Falls Church, VA)
- …share our vision to create extraordinary experiences, you belong at HITT. Associate , PayrollJob Description: The Payroll Associate will process weekly ... validations, and reconciliation for approximately 1,500 team members. The Payroll Associate will comply with the policies/procedures of HITT Contracting, affiliated… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- Overview The Weigh and Dispense Associate position is responsible for assisting with and executing the set-up, weighing of raw materials, solvents, and solutions ... to weigh and dispense, including supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes,… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- Overview The Weigh and Dispense Associate position is responsible with assisting and executing in the set-up, and weighing of raw materials, solvents, and solutions ... to weigh and dispense, including supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes,… more
- Mindlance (West Palm Beach, FL)
- Job Title: Contract Coordinator, Associate Job Location: Juno Beach FL 33408 Top 3/5 Skills: Completed Bachelor's Degree Strong knowledge of Contracts management & ... conditions for deferral programs, ensuring the company's best interests are protected. Review and analyze financial data to assess the feasibility and effectiveness… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- Overview The Associate Director, Process Analytics is the system owner for this function, focusing on the drug substance manufacturing at FDBN. This role sets up and ... and clients) for data used to support continuous manufacturing and validation , continuous improvement and regulatory commitments Leads innovations and systems… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …this posting represents 3 openings External US About This Role The manufacturing associate in Drug Product Manufacturing will have a primary task for operation of ... manufacturing Possible assignments include: Supporting projects related to procedure review and/or creation, development or transfer of manufacturing business… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …Holly Springs Site! External US About This RoleThe role as Manufacturing Associate 4 will execute manufacturing processing steps and associated activities. This ... manufacturingPossible assignments include: Supporting projects related to - Procedure review and/or creation, development or transfer of manufacturing business… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …product manufacturingPossible assignments include, supporting projects related to procedure review and/or creation, development or transfer of manufacturing business ... and control Perform in-process testing (pH, conductivity, visual inspection)Execute validation protocols according to cGMP Standard Operating Procedures (SOPs)Maintain… more
