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  1. Senior Medical Writer

    Must have: Strong Phase III regulatory writing experience AND PK/PD Phase I writing experience Therapeutic area experience in: oncology and/or endocrinology Duties and Responsibilities   % of Time Provide medical writing support for development programs by hands-on writing of protocols, IBs, and CSRs. Participate in appropriate development teams and internal strategy and operations meetings. 60% Manage/Assist documents through the review process (coordinating ...

  2. Analytical Biochemistry CRO Administration Manager - Princeton, NJ

    Seeking Ph.D. in biochemistry, toxicology, bioanalytics or similar field and 10 + years of experience managing pharmaceutical development bioanalytics projects using Contract Research Organizations. Must have thorough knowledge of scientific operations, management, technical and administrative functions of the laboratory. Shall: *** Sources, qualifies, hires and directs CRO core activities, including method development, method validation and sample analysis for global regulatory submission. *** ...

  3. Mgr - QAIG Lab Support

    Actavis, Inc. Job Purpose The QA Manager of Laboratory Systems Support is responsible for the general oversight of Actavis Laboratory Systems specific (but not limited) to Deviations & CAPAs (non-lab), Complaints, Laboratory Equipment/Utilities Qualifications, Change Control, Method Validation, and Analytical Documentation. Description of KEY responsibilities: * Manage the QA Laboratory Systems Support department while maintaining a high quality standard in accordance with GMP, SOP, FDA and OSHA ...

  4. Pharm Tech Specialist I - Actavis, Inc.

    The Pharm Tech Specialist is responsible for supporting validation activities as it pertains to manufacturing and cleaning processes at the Actavis Elizabeth LLC facility per the framework of the Validation Master Plans. Description of key responsibilities: * Complete assignments pertaining to qualification/validation of processes and cleaning in support of manufacturing of new and existing products. Typical assignments at this level would advance to include (but not limited to) development of ...

  5. QA/QC Specialist III

    PRIMARY RESPONSIBILITIES: 1. Oversee batch production. 2. Prepare intermediate batch records and assign numbers regarding quality control issues in manufacturing process for late shift (1:00pm to close). 3. Archive old paperwork, file released and completed paperwork. 4. Record and monitor PH of waste water and keep appropriate logs. 5. Prepare batch records daily and assign batch numbers. 6. Daily entry of specific gravity results in computer. 7. Annual review of drug product and stability program. ...

  6. The Head of Quality Systems, Life Sciences Job

    GE Healthcare GE is an equal opportunity employer, offering a great work environment, challenging career opportunities, professional training and competitive compensation. The Head of Quality Systems provides leadership and direction for the quality management system-LS. This position has accountability for the decisions affecting quality and compliance of key quality management systems impacting Life Sciences Essential Responsibilities: - Translates Global Quality Assurance vision into ...

  7. Senior Coatings Chemist

    OVERALL RESPONSIBILITIES: Evaluates and executes technical service projects in area of paints and coatings for internal and external customers.  Formulates paints and construction products that are used to evaluate additives.  Develops new aqueous and solvent based additives for enhancing the performance of paints and coatings.  Provides solutions to customer problems using Troy additives. Mentors Coatings Chemists and Technicians by assisting them in project planning, test method selection, and ...