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document control in Raleigh

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  1. Quality Control Analyst I- 3921347

    Support organization and start-up of the QC laboratory.   Execute method validation and transfers for assigned assays. Execute assigned testing. Ensure that the samples are tested according to quality requirements defined via registered specifications in accordance with local/international regulations.   Ensure results reported are valid, accurate and documented per applicable regulatory and corporate requirements.   Duties: Laboratory Function Perform assigned testing Participate in ...

  2. Senior Clinical Research Associate

    We are looking for CRAs with at least 6 years monitoring experience and 3-4 years in Oncology .  .   Responsibilities: MONITORING – Preparation, conduct, and reporting of selection, initiation/startup, routine/interim and closeout monitoring visits, Site management, Assistance at internal and third-party audits).  Assures timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations.  Maintains regular review of site regulatory binder and ensures proper storage, ...

  3. 3919367 – QC Data Reviewer

    This position provides operational Phase Support organization of the QC Analytical, Biochemistry, and Raw Materials laboratory.  The successful candidate will plan and assist with required resources for day to day data review of raw data generated in the QC laboratories. You must have strong scientific and data review background as to provide technical knowledge and quality comments associated with raw data review and documentation.       RESPONSIBILITIES:   Perform timely data review with a ...

  4. Quality Control Associate

      My name is Starr and I represent The Fountain Group.  We are a national staffing firm and are currently seeking a Quality Control Associate for a prominent client of ours.  This position is located in RTP, NC. Details for the positions are as follows:   Job Description:   The primary responsibility for a Quality Control Associate I is the execution of QC environmental monitoring, routine testing and all activities associated with executing this testing in a cGMP manner. Additional ...

  5. Change Control Supervisor

    Description PSC Biotech Corporation is a global, employee owned, life sciences consultancy that performs projects and staff augmentation in the following disciplines: Engineering, Information Technology, Technical Services, Validation, Compliance, Regulatory Submissions, Clinical, Project Management and Quality Assurance. PSC Biotech, incorporated in 1996, has been performing projects globally for over 15 years. PSC Biotech is currently looking for a Change Control Supervisor for our client in ...

  6. 3888627 – QC Data Reviewer

    This position provides operational Phase Support organization of the QC Analytical, Biochemistry, and Raw Materials laboratory.  The successful candidate will plan and assist with required resources for day to day data review of raw data generated in the QC laboratories. You must have strong scientific and data review background as to provide technical knowledge and quality comments associated with raw data review and documentation.       RESPONSIBILITIES:   Perform timely data review with a ...

  7. 3881470 – QA Specialist

    Responsibilities:   Supports the development and maintenance of quality procedures, and systems related to Primary Manufacturing Quality Assurance oversight. Provides technical support for the US FCC site in all cGMP compliance related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the company Quality Manual requirements. Ensures that all aspects of USFCC operations comply with the requirements of the Quality manual and meets all relevant ...

  8. 3881470 – QA Specialist

    Responsibilities: • Supports the development and maintenance of quality procedures, and systems related to Primary Manufacturing Quality Assurance oversight. • Provides technical support for the US FCC site in all cGMP compliance related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the company Quality Manual requirements. • Ensures that all aspects of USFCC operations comply with the requirements of the Quality manual and meets all relevant ...